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平成29年11月17日作成
一般的名称及び販売名
一般的名称： (1)胆管用ステント (2)胆管用ステント 販売名 ： (1)EGIS胆管ステント カバード (2)EGIS胆管ステント ベアー
対象ロット、数量及び出荷時期
(1)EGIS胆管ステント カバード（以下、「品番：MD-○○○○○」、以降はシリアル番号） 品番：MD-DCE08 K7B048GCB303, K7B049GCB304, K7B050GCB305, K7B118GCB319, K7B119GCB320 K7B131GCB306, K7B132GCB307, K7B151GCB321, K7B152GCB322, K7B159GCB308 K7B160GCB309, K7B161GCB310, K7B175GCB323, K7B186GCB324, K7B214GCB316 K7B215GCB317, K7B219GCB326, K7B222GCB311, K7B223GCB312, K7B224GCB313 K7B248GCB318, K7B256GDB260, K7B257GDB261, K7B282GEB220, K7B284GCB314 K7B285GCB315, K7C068GDB265, K7C069GDB266, K7C103GDB255, K7C121GDB256 K7C122GDB257, K7C164GDB258, K7C165GDB259, K7D021GDB353, K7D022GDB354 K7D029GDB357, K7D040GDB262, K7D041GDB263, K7D042GDB264, K7D046GDB355 K7D047GDB356, K7D348GEB207, K7D349GEB208, K7D350GEB209, K7D351GEB210 K7D352GEB211, K7D358GEB212, K7D359GEB213, K7D364GEB215, K7D365GEB216 K7D366GEB217, K7D370GEB218, K7D371GEB219, K7D374GEB221, K7D375GEB222 K7D376GEB223, K7D380GEB224, K7D382GEB226, K7D413GDB405, K7D567GEB464 K7D568GEB465, K7D569GEB466, K7D630GEB468, K7D631GEB469, K7D636GEB473 K7D637GEB474, K7D732GEB481, K7D733GEB482 小計：68個 品番：MD-DCE10 V7B021GCB327, V7B022GCB328, V7B023GCB329, V7B024GCB330, V7B025GCB331 V7B037GCB332, V7B039GCB334, V7B040GCB335, V7B041GCB336, V7B051GCB347 V7B052GCB348, V7B053GCB349, V7B054GCB350, V7B055GCB351, V7B056GCB352 V7B057GCB353, V7B058GCB354, V7B059GCB355, V7B060GCB356, V7B061GCB357 V7B063GCB359, V7B064GCB360, V7B065GCB361, V7B066GCB362, V7B067GCB363 V7B068GCB364, V7B069GCB365, V7B070GCB366, V7B111GCB367, V7B112GCB368 V7B113GCB369, V7B114GCB370, V7B115GCB371, V7B116GCB372, V7B117GCB373 V7B118GCB374, V7B119GCB375, V7B120GCB376, V7B122GCB378, V7B123GCB379 V7B124GCB380, V7B125GCB381, V7B126GCB382, V7B127GCB383, V7B128GCB384 V7B129GCB385, V7B130GCB386, V7B155GCB387, V7B156GCB388, V7B157GCB389 V7B158GCB390, V7B159GCB391, V7B160GCB392, V7B161GCB393, V7B162GCB394 V7B163GCB395, V7B164GCB396, V7B166GCB398, V7B167GCB399, V7B168GCB400 V7B169GCB401, V7B171GCB403, V7B172GCB404, V7B173GCB405, V7B174GCB406 V7B235GCB337, V7B236GCB338, V7B237GCB339, V7B238GCB340, V7B239GCB341 V7B240GCB342, V7B241GCB343, V7B242GCB344, V7B243GCB345, V7B244GCB346 V7C101GDB267, V7C102GDB268, V7C105GDB269, V7C106GDB270, V7C107GDB271 V7C108GDB272, V7C109GDB273, V7C117GDB274, V7C119GDB276, V7C120GDB277 V7C121GDB278, V7C122GDB279, V7C123GDB280, V7C124GDB281, V7C126GDB283 V7C127GDB284, V7C128GDB285, V7C129GDB286, V7C130GDB287, V7C131GDB288 V7C132GDB289, V7C227GDB299, V7C228GDB300, V7C229GDB301, V7C230GDB302 V7C231GDB303, V7C232GDB304, V7C234GDB306, V7C235GDB307, V7C236GDB308 V7C237GDB309, V7C273GDB321, V7C274GDB322, V7C275GDB323, V7C276GDB324 V7C277GDB325, V7C278GDB326, V7C279GDB327, V7C280GDB328, V7C281GDB329 V7C282GDB330, V7C283GDB331, V7C285GDB333, V7C313GDB341, V7C314GDB342 V7C315GDB343, V7C316GDB344, V7C317GDB345, V7C318GDB346, V7C319GDB347 V7C320GDB348, V7C321GDB349, V7C322GDB350, V7C323GDB351, V7D005GDB352 V7D138GEB227, V7D139GEB228, V7D140GEB229, V7D260GEB230, V7D261GEB231 V7D262GEB232, V7D264GEB234, V7D265GEB235, V7D266GEB236, V7D311GEB256 V7D324GEB262, V7D504GDB407, V7D506GDB406, V7D734GEB489, V7D735GEB490 V7D736GEB491, V7D737GEB492 小計：147個 品番：MD-DCP08 K7B030GCB064, K7B031GCB065, K7B046GCB030, K7B047GCB031, K7B051GCB032 K7B074GCB033, K7B075GCB034, K7B076GCB035, K7B077GCB036, K7B078GEB063 K7B079GEB064, K7B080GCB037, K7B081GCB038, K7B082GCB039, K7B092GCB044 K7B093GCB045, K7B094GCB046, K7B095GCB047, K7B122GCB048, K7B123GCB049 K7B130GCB040, K7B155GCB050, K7B156GCB051, K7B176GCB066, K7B181GCB052 K7B182GCB053, K7B185GCB041, K7B249GDB059, K7B292GCB054, K7B293GCB055 K7B294GCB056, K7B295GCB057, K7B296GCB058, K7B297GCB059, K7B298GCB060 K7B299GCB061, K7B300GCB062, K7B301GCB063, K7B312GCB042, K7B313GCB043 K7B316GCB067, K7B317GCB068, K7B318GCB069, K7B319GCB070, K7B320GCB071 K7B321GCB072, K7B322GCB073, K7B323GCB074, K7B324GCB075, K7B325GCB076 K7B326GCB077, K7B327GCB078, K7B329GCB080, K7B330GCB081, K7B331GCB082 K7B332GCB083, K7C166GDB058, K7D117GEB110, K7D118GEB111, K7D137GEB065 K7D138GEB066, K7D139GEB067, K7D140GEB068, K7D141GEB069, K7D142GEB070 K7D143GEB071, K7D144GEB072, K7D145GEB073, K7D146GEB074, K7D147GEB075 K7D148GEB076, K7D149GEB077, K7D150GEB078, K7D151GEB079, K7D152GEB080 K7D153GEB081, K7D154GEB082, K7D155GEB083, K7D156GEB084, K7D157GEB085 K7D158GEB086, K7D159GEB087, K7D183GEB088, K7D184GEB089, K7D185GEB090 K7D186GEB091, K7D187GEB092, K7D188GEB093, K7D189GEB094, K7D190GEB095 K7D191GEB096, K7D192GEB097, K7D193GEB098, K7D194GEB099, K7D195GEB100 K7D196GEB101, K7D197GEB102, K7D198GEB103, K7D199GEB104, K7D219GEB112 K7D220GEB113, K7D221GEB114, K7D222GEB115, K7D223GEB116, K7D224GEB117 K7D225GEB118, K7D226GEB119, K7D227GEB120, K7D228GEB121, K7D229GEB122 K7D230GEB123, K7D231GEB124, K7D232GEB125, K7D233GEB126, K7D234GEB127 K7D235GEB128, K7D411GDB403, K7D495GEB324, K7D496GEB325, K7D497GEB326 K7D498GEB327, K7D499GEB328, K7D500GEB329, K7D501GEB330, K7D502GEB331 K7D503GEB332, K7D504GEB333, K7D506GEB335, K7D507GEB336, K7D571GEB374 小計：130個 品番：MD-DCP10 V7B026GCB084, V7B027GCB085, V7B028GCB086, V7B042GCB087, V7B043GCB088 V7B071GCB089, V7B072GCB090, V7B073GCB091, V7B074GCB092, V7B075GCB093 V7B076GCB094, V7B077GCB095, V7B079GCB097, V7B080GCB098, V7B131GCB099 V7B132GCB100, V7B175GCB101, V7B176GCB102, V7B177GCB103, V7B178GCB104 V7B179GCB105, V7B180GCB106, V7B181GCB107, V7B182GCB108, V7B183GCB109 V7B184GCB110, V7B185GCB111, V7B186GCB112, V7B187GCB113, V7B188GCB114 V7B189GCB115, V7B190GCB116, V7B191GCB117, V7B192GCB118, V7B193GCB119 V7B194GCB120, V7C110GDB060, V7C249GDB061, V7D141GEB106, V7D161GEB139 V7D254GEB107, V7D255GEB108, V7D256GEB109, V7D274GEB135, V7D275GEB136 V7D276GEB137, V7D277GEB138, V7D296GEB140, V7D297GEB141, V7D298GEB142 V7D299GEB143, V7D300GEB144, V7D301GEB145, V7D302GEB146, V7D502GDB404 V7D652GEB424, V7D653GEB425, V7D654GEB426, V7D655GEB427, V7D656GEB428 V7D657GEB429, V7D658GEB430, V7D659GEB431, V7D660GEB432, V7D672GEB404 V7D673GEB405 小計：66個 出荷数合計：411個 出荷時期 ：2017年3月27日〜2017年11月7日 (2)EGIS胆管ステント ベアー（以下、「品番：MD-○○○○○」、以降はシリアル番号） 品番：MD-DBE08 K7B228GCB277, K7B229GCB278, K7B230GCB279, K7B235GCB282, K7B238GCB287 K7B239GCB288, K7B252GDB098, K7B253GCB289, K7B260GCB267, K7B261GCB268 K7B262GCB269, K7B288GCB290, K7B289GCB291, K7B371GCB270, K7B372GCB271 K7B375GCB272, K7B376GCB273, K7B377GCB274, K7B378GCB275, K7B379GCB276 K7B385GCB280, K7B386GCB281, K7B389GCB283, K7B390GCB284, K7B392GCB286 K7B397GCB292, K7B398GCB293, K7B399GCB294, K7B403GCB295, K7B404GCB296 K7B405GCB297, K7B406GCB298, K7C043GDB082, K7C044GDB083, K7C045GDB084 K7C046GDB085, K7C053GDB094, K7C055GEB156, K7C060GDB087, K7C083GDB096 K7C084GDB097, K7C088GDB099, K7C105GEB157, K7C211GDB080, K7C212GDB081 K7C216GDB086, K7C218GDB088, K7C219GDB089, K7C220GDB090, K7C224GEB158 K7C226GEB159, K7C270GDB091, K7C271GDB092, K7C272GDB093, K7D015GDB100 K7D016GDB101, K7D017GDB102, K7D038GDB103, K7D113GEB162, K7D114GEB163 K7D265GEB147, K7D266GEB148, K7D267GEB149, K7D271GEB150, K7D272GEB151 K7D277GEB153, K7D279GEB155, K7D283GEB160, K7D284GEB161, K7D287GEB164 K7D409GDB408, K7D738GEB506, K7D740GEB507, K7D742GEB508, K7D743GEB509 K7D744GEB510, K7D748GEB511, K7D749GEB512, K7D750GEB513, K7D754GEB514 K7D755GEB515, K7D756GEB516, K7D760GEB517, K7D761GEB518 小計：84個 品番：MD-DBE10 V7B011GCB121, V7B012GCB122, V7B013GCB123, V7B271GCB124, V7B272GCB125 V7B273GCB126, V7B274GCB127, V7B275GCB128, V7B276GCB129, V7B277GCB130 V7B278GCB131, V7B279GCB132, V7B280GCB133, V7B281GCB134, V7B282GCB135 V7B283GCB136, V7B284GCB137, V7B287GCB140, V7B288GCB141, V7B289GCB142 V7B290GCB143, V7B291GCB144, V7B292GCB145, V7B293GCB146, V7B294GCB147 V7B295GCB148, V7B296GCB149, V7B297GCB150, V7B298GCB151, V7B299GCB152 V7B300GCB153, V7B333GCB154, V7B334GCB155, V7B335GCB156, V7B336GCB157 V7B337GCB158, V7B338GCB159, V7B339GCB160, V7B340GCB161, V7B341GCB162 V7B342GCB163, V7B343GCB164, V7B344GCB165, V7B345GCB166, V7B346GCB167 V7B347GCB168, V7B350GCB171, V7B351GCB172, V7B352GCB173, V7B353GCB174 V7B354GCB175, V7B355GCB176, V7B356GCB177, V7B357GCB178, V7B359GCB180 V7B360GCB181, V7B361GCB182, V7B362GCB183, V7B417GCB184, V7B418GCB185 V7B419GCB186, V7B420GCB187, V7B421GCB188, V7B422GCB189, V7B423GCB190 V7B424GCB191, V7B425GCB192, V7B426GCB193, V7B427GCB194, V7B428GCB195 V7B430GCB197, V7B431GCB198, V7B432GCB199, V7B433GCB200, V7B434GCB201 V7B435GCB202, V7B436GCB203, V7B437GCB204, V7B438GCB205, V7B439GCB206 V7B440GCB207, V7B441GCB208, V7B442GCB209, V7B443GCB210, V7B444GCB211 V7B445GCB212, V7B446GCB213, V7B479GCB214, V7B480GCB215, V7B481GCB216 V7B482GCB217, V7B483GCB218, V7B484GCB219, V7B485GCB220, V7B486GCB221 V7B487GCB222, V7B488GCB223, V7B489GCB224, V7B490GCB225, V7B491GCB226 V7B492GCB227, V7B495GCB230, V7B496GCB231, V7B497GCB232, V7B498GCB233 V7B499GCB234, V7B500GCB235, V7B501GCB236, V7B502GCB237, V7B503GCB238 V7B504GCB239, V7B505GCB240, V7B506GCB241, V7B507GCB242, V7B508GCB243 V7B546GCB245, V7B547GCB246, V7B548GCB247, V7B549GCB248, V7B550GCB249 V7B551GCB250, V7B552GCB251, V7B553GCB252, V7B554GCB253, V7B555GCB254 V7B556GCB255, V7B557GCB256, V7B558GCB257, V7B559GCB258, V7B575GCB259 V7B576GCB260, V7B577GCB261, V7B578GCB262, V7B579GCB263, V7C338GDB106 V7C339GDB107, V7C340GDB108, V7C341GDB109, V7C342GDB110, V7C343GDB111 V7C344GDB112, V7C345GDB113, V7C346GDB114, V7C347GDB115, V7C348GDB116 V7C349GDB117, V7C350GDB118, V7C352GDB120, V7C389GDB232, V7C390GDB233 V7C391GDB234, V7C392GDB235, V7C394GDB237, V7C395GDB238, V7C396GDB239 V7C397GDB240, V7C398GDB241, V7C399GDB242, V7C400GDB243, V7C401GDB244 V7C402GDB245, V7C403GDB246, V7C404GDB247, V7C421GDB248, V7C422GDB249 V7C423GDB250, V7C424GDB251, V7C425GDB252, V7C521GDB197, V7C522GDB198 V7C523GDB199, V7C524GDB200, V7C525GDB201, V7C526GDB202, V7C527GDB203 V7C528GDB204, V7C529GDB205, V7C530GDB206, V7C531GDB207, V7C532GDB208 V7C533GDB209, V7C534GDB210, V7C535GDB211, V7C536GDB212, V7C537GDB213 V7C538GDB214, V7C539GDB215, V7C540GDB216, V7C541GDB217, V7C677GDB166 V7C678GDB167, V7C679GDB168, V7C680GDB169, V7C681GDB170, V7C682GDB171 V7C683GDB172, V7C684GDB173, V7C685GDB174, V7C686GDB175, V7C687GDB176 V7C688GDB177, V7C689GDB178, V7C690GDB179, V7C691GDB180, V7C692GDB181 V7C693GDB182, V7C694GDB183, V7C695GDB184, V7C751GDB131, V7C752GDB132 V7C753GDB133, V7C754GDB134, V7C755GDB135, V7C756GDB136, V7C757GDB137 V7C758GDB138, V7C759GDB139, V7C761GDB141, V7C762GDB142, V7C763GDB143 V7C764GDB144, V7C766GDB146, V7C767GDB147, V7C768GDB148, V7C769GDB149 V7C770GDB150, V7C771GDB151, V7C772GDB152, V7C773GDB153, V7C774GDB154 V7C775GDB155, V7C776GDB156, V7C777GDB157, V7C778GDB158, V7D001GDB253 V7D002GDB254, V7D170GEB165, V7D171GEB166, V7D172GEB167, V7D173GEB168 V7D174GEB169, V7D216GEB180, V7D217GEB181, V7D508GDB409, V7D510GDB410 小計：245個 品番：MD-DBP08 K7B127GCB005, K7B234GCB006, K7B350GCB001, K7B352GCB002, K7B353GCB003 K7B356GCB007, K7B358GCB008, K7B359GCB009, K7C042GDB065, K7C052GDB069 K7C061GDB066, K7C062GDB067, K7C063GDB068, K7C087GDB070, K7C160GDB062 K7C161GDB063, K7C210GDB064 小計：17個 品番：MD-DBP10 V7B014GCB010, V7B015GCB011, V7B269GCB012, V7B270GCB013, V7B363GCB014 V7B364GCB015, V7B365GCB016, V7B366GCB017, V7B367GCB018, V7B368GCB019 V7B369GCB020, V7B370GCB021, V7B371GCB022, V7B372GCB023, V7B415GCB025 V7B416GCB026, V7B509GCB027, V7B510GCB028, V7C335GDB071, V7C337GDB072 V7C556GDB077, V7C557GDB078, V7C558GDB079, V7C708GDB076 小計：24個 出荷数合計：370個 出荷時期 ：2017年3月27日〜2017年11月7日
製造販売業者等名称
製造販売業者の名称 ： 秋田住友ベーク株式会社 製造販売業者の所在地： 秋田県秋田市土崎港相染町字中島下27-4 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： 05B1X00002
回収理由
本品に使用の一部の原材料および一部の物性規格が、承認された内容から逸脱する可能性が確認されました。 調査の結果、上記の品番、ロット番号の製品において自主回収することと致しました。
危惧される具体的な健康被害
本品の該当の原材料は、ステントのデリバリー操作の際、直接的、または間接的に胆管の組織表面と接触します が、接触時間はごく僅かであり、この接触により健康被害が発生する可能性は極めて低いと考えられます。 また、物性規格について承認書から逸脱する程度・頻度は僅かなものでした。本品は医療従事者の確認のもとに 透視下で胆管内に留置されますので、物性規格の逸脱による不具合が発生した場合、適切に処置することが可能 なことから、重篤な健康被害には至らないものと考えられます。 よって、何れの場合においても、患者に重篤な健康被害が発生する可能性はないと考えられます。 なお、現在までに、当該品の使用による健康被害の報告はありません。
回収開始年月日
平成29年11月16日
効能・効果又は用途等
本品は、胆管に留置して使用するステントであります。ステントは網状で自動拡張機能を有し、デリバリーシス テムに装填されています。
その他
当該ロットの出荷先は全て把握しておりますので、出荷先に対して当該品を自主回収する旨を通知し、適切に回 収を実施いたします。
担当者及び連絡先
担当者 ： 大西 忠之 連絡先 ： 秋田住友ベーク株式会社 信頼性保証部 秋田県秋田市土崎港相染町字中島下27-4 電話番号： 018-846-6891 FAX番号 ： 018-847-2725