令和 3年 3月10日作成

一般的名称： 送気送水機能付内視鏡用光源・プロセッサ装置
販売名　　： EVIS X1 ビデオシステムセンター OLYMPUS CV-1500

製品名称：CV-1500
製造番号：
7011168,7011169,7011170,7011171,7011172,7011173,7011174,7011175,7011176,7011177,7011178,7011179,7011
188,7011189,7011190,7011191,7011192,7011193,7011194,7011195,7011196,7011197,7011198,7011199,7011200,
7011201,7011202,7011203,7011204,7011205,7011206,7011207,7011208,7011209,7011210,7011211,7011212,7011
213,7011214,7011215,7011216,7011217,7011218,7011219,7011220,7011221,7011222,7011223,7011224,7011225,
7011226,7011227,7021258,7021259,7021260,7021261,7021262,7021263,7021264,7021265,7021266,7021267,7021
268,7021269,7021270,7021271,7021272,7021273,7021274,7021275,7021276,7021277,7021278,7021280,7021281,
7021282,7021283,7021284,7021285,7021286,7021287,7021288,7021289,7021290,7021291,7021292,7021293,7021
294,7021295,7021296,7021297,7021298,7021299,7021300,7021301,7021302,7021303,7021304,7021305,7021306,
7021307,7021308,7021309,7021310,7021312,7021314,7021316,7021317,7021326,7021327,7021328,7021329,7021
333,7021334,7021335,7021336,7021337,7021338,7021339,7021340,7021341,7021342,7021343,7021344,7021345,
7021346,7021347,7021348,7021349,7021350,7021351,7021352,7021353,7021354,7021355,7021356,7021357,7021
363,7021364,7021365,7021366,7021367,7021368,7021369,7021370,7021371,7021372,7021373,7021374,7021375,
7021376,7021377,7021378,7021379,7021380,7021381,7021382,7021383,7021384,7021385,7021386,7021387,7021
388,7021389,7021390,7021391,7021392,7021393,7021394,7021395,7021396,7021397,7021398,7021399,7021400,
7021401,7021402,7021403,7021404,7021405,7021406,7021407,7021408,7021409,7021410,7021411,7021412,7021
413,7021414,7021415,7021416,7021417,7021418,7021419,7021420,7021421,7021422,7021423,7021424,7021425,
7021426,7021427,7021428,7021429,7021430,7021431,7021432,7021433,7021434,7021435,7021436,7021437,7021
453,7021454,7021455,7021456,7021457,7021458,7021459,7021460,7021461,7021462,7021463,7021464,7021465,
7021466,7021467,7021468,7021469,7021470,7021471,7021472,7021473,7021474,7021475,7021476,7021477,7021
478,7021479,7021480,7021481,7021482,7021483,7021484,7021485,7021486,7021487,7021488,7021489,7021490,
7021491,7021493,7021494,7021495,7021496,7021497,7021498,7021499,7021500,7021501,7021502,7021503,7021
504,7021505,7021506,7021507,7021508,7021509,7021510,7021511,7021512,7021513,7021514,7021515,7021516,
7021517,7021518,7021519,7021520,7021521,7021522,7021523,7021524,7021525,7021526,7021527,7021528,7021
529,7021530,7021531,7021532,7021533,7021534,7021661,7021662,7021663,7021664,7021665,7021666,7021667,
7021668,7021670,7021671,7021673,7021674,7021675,7021676,7021677,7021678,7021679,7021680,7021681,7021
682,7021683,7021684,7021685,7021686,7021687,7021688,7021689,7021690,7021691,7021692,7021693,7021694,
7021695,7021696,7021697,7021698,7021699,7021700,7021701,7021702,7021703,7021704,7021705,7021706,7021
707,7021708,7021709,7021710,7021711,7021712,7021713,7021714,7021715,7021716,7021717,7021718,7021719,
7021720,7021721,7021722,7021723,7021724,7021725,7021726,7021727,7021728,7021729,7021730,7021731,7021
732,7021733,7021734,7021735,7021736,7021737,7021738,7021739,7021740,7021741,7021742,7021743,7021744,
7021745,7021746,7021747,7021748,7021749,7021750,7021751,7021752,7021753,7021754,7021755,7021756,7021
757,7021758,7021759,7021760,7021761,7021762,7021763,7021764,7021765,7021766,7021767,7021768,7021787,
7021788,7021789,7021790,7021791,7021792,7021793,7021805,7021806,7021807,7021808,7021809,7021810,7021
811,7021812,7021813,7021814,7021815,7021816,7021817,7021818,7021819,7021820,7021821,7021822,7021823,
7021824,7021825,7021826,7021827,7021828,7021829,7021830,7021831,7021832,7021833,7021834,7021835,7021
836,7021837,7021838,7021839,7021840,7021841,7021842,7021843,7021844,7021845,7021846,7021847,7021848,
7021849,7021850,7021851,7021852,7021853,7021854,7021855,7021856,7021857,7021858,7021859,7021860,7021
861,7021862,7021863,7021864,7021865,7021866,7021867,7021868,7021869,7021870,7021871,7021872,7021873,
7021874,7021875,7021876,7021877,7021878,7021879,7021880,7021881,7021882,7021883,7021884,7021885,7021
886,7021887,7021888,7021889,7021890,7021891,7021892,7021893,7021894,7021949,7021950,7021951,7021952,
7021953,7021954,7021955,7021956,7021957,7021958,7021959,7021960,7021961,7021962,7021963,7021964,7021
965,7021966,7022120,7022121,7022122,7022123,7022124,7022125,7022126,7022127,7022128,7022129,7022130,
7022131,7022132,7022133,7022134,7022135,7022136,7022137,7022139,7022142,7022143,7022144,7022145,7022
146,7022147,7022148,7022149,7022150,7022151,7022152,7022153,7022154,7022155,7022156,7022157,7022158,
7022159,7022160,7022161,7022162,7022163,7022164,7022165,7022166,7022167,7022168,7022169,7022170,7022
171,7022172,7022173,7022174,7022175,7022176,7022177,7022178,7022179,7022180,7022181,7022182,7022183,
7022184,7022185,7022186,7022187,7022188,7022189,7022190,7022191,7022192,7022193,7022194,7022195,7022
196,7022197,7022198,7022199,7022200,7022201,7022202,7022203,7022204,7022205,7022206,7022207,7022208,
7022209,7022210,7022211,7022212,7022213,7022214,7022215,7022216,7022217,7022218,7022219,7022220,7022
221,7022222,7022223,7022224,7022225,7022226,7022227,7022228,7022229,7022398,7022399,7022400,7022401,
7022402,7022405,7022406,7022407,7022408,7022409,7022410,7022411,7022412,7022413,7022414,7022426,7022
427,7022428,7022429,7022430,7022431,7022432,7022433,7022434,7022435,7022436,7022437,7022438,7022439,
7022440,7022441,7022442,7022443,7022444,7022445,7022446,7022447,7022448,7022449,7022450,7022451,7022
452,7022453,7022455,7022456,7022457,7022458,7022459,7022460,7022461,7022462,7022463,7022464,7022465,
7022466,7022473,7022474,7022475,7022477,7022478,7022479,7022480,7022481,7022482,7022483,7022484,7022
485,7022486,7022487,7022488,7022489,7022490,7022491,7022492,7022494,7022495,7022496,7022497,7022498,
7022499,7022500,7022501,7022503,7022505,7022506,7022507,7022508,7022509,7022510,7022511,7022512,7022
513,7022514,7022515,7022516,7022517,7022518,7022519,7022521,7022522,7022523,7022524,7022525,7022526,
7022528,7022529,7022530,7022531,7022533,7022534,7022535,7022536,7022537,7022538,7022539,7022540,7022
541,7022542,7022543,7022544,7022545,7022546,7022549,7022550,7022551,7022552,7022553,7022554,7022555,
7022556,7022557,7022558,7022559,7022560,7022561,7022562,7022563,7022564,7022565,7022566,7022572,7022
576,7022577,7022578,7022579,7022581,7022584,7022585,7022586,7022587,7022588,7022589,7022590,7022591,
7022592,7022593,7022594,7022595,7022596,7022597,7022598,7022599,7022600,7022601,7022602,7022604,7022
605,7022606,7022607,7022612,7022613,7022614,7022615,7022616,7022618,7022619,7022620,7022621,7022622,
7022623,7022624,7022625,7022626,7022627,7022628,7022630,7022631,7022633,7022634,7022635,7022636,7022
637,7022638,7022639,7022640,7022641,7022642,7022643,7022644,7022645,7022646,7022647,7022648,7022649,
7022652,7022653,7022654,7022655,7022656,7022658,7022662,7022663,7022664,7022666,7022668,7022669,7022
670,7022671,7022672,7022673,7022674,7022676,7022677,7022678,7022679,7022680,7022681,7022682,7022683,
7022684,7022685,7022686,7022687,7022688,7022689,7022690,7022691,7022692,7022696,7022698,7022699,7022
700,7022701,7022702,7022703,7022704,7022706,7022707,7022708,7022709,7022710,7022712,7022713,7022715,
7022716,7022717,7022718,7022719,7022720,7022722,7022723,7022724,7022726,7022727,7022728,7022729,7022
730,7022731,7022732,7022733,7022734,7022735,7022736,7022737,7022738,7022739,7022740,7022741,7022742,
7022743,7022744,7022745,7022746,7022747,7022748,7022749,7022750,7022751,7022752,7022753,7022754,7022
755,7022756,7022757,7022758,7022759,7022762,7022763,7022764,7022765,7022767,7022768,7022769,7022770,
7022771,7022772,7022773,7022774,7022775,7022777,7022778,7022779,7022780,7022781,7022782,7022783,7022
785,7022786,7022787,7022790,7022792,7022793,7022794,7022796,7022797,7022799,7022800,7022802,7022804,
7022805,7022806,7022808,7022809,7022810,7022811,7022812,7022813,7022814,7022815,7022816,7022817,7023
156,7023157,7023162,7023163,7023164,7023165,7023166,7023167,7023168,7023170,7023171,7023181,7023183,
7023184,7023185,7023188,7023189,7023191,7023193,7023194,7023195,7023196,7023197,7023198,7023200,7023
201,7023202,7023203,7023205,7023206,7023207,7023208,7023210,7023211,7023213,7023215,7023217,7023219,
7023220,7023222,7023223,7023224,7023225,7023226,7023227,7023228,7023229,7023230,7023231,7023232,7023
233,7023234,7023235,7023236,7023237,7023239,7023240,7023241,7023242,7023244,7023245,7023246,7023247,
7023248,7023249,7023250,7023251,7023252,7023254,7023256,7023261,7023263,7023264,7023267,7023268,7023
287,7023288,

数量：　1039台
出荷時期：令和２年６月２日〜令和３年２月１２日

製造販売業者の名称　： オリンパスメディカルシステムズ株式会社　八王子事業所
製造販売業者の所在地： 東京都八王子石川町２９５１
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 13B1X00277

(1)弊社製「内視鏡マネジメントシステム（以下、Solemio）」を組み合わせてご使用いただく際、特定の操作手
順を行うと当該製品から入力、選択した患者情報と異なる情報が観察モニターに表示される現象が確認されまし
たので、不具合を改善したプログラムに改修いたします。

(2)弊社製「上部消化管汎用ビデオスコープ　OLYMPUS GIF-EZ1500」、「大腸ビデオスコープ　OLYMPUS　CF-EZ1
500DL」、及び、「大腸ビデオスコープ　OLYMPUS　CF-EZ1500DI」と組合せて使用した際に、特定の条件下で、
照明レンズが粘膜に接触した状態が続きますと内視鏡照明光の過度な照射により粘膜が変性する可能性があるこ
とがわかりました。そのため、不具合を改善したプログラムに改修いたします。また、CV-1500とGIF-EZ1500、
CF-EZ1500DL、CF-EZ1500DIの内視鏡を組み合わせて使用する際の注意事項を記載した文書の配付を行います。

(1)処置開始前に観察モニターへの患者情報表示と患者自身との一致確認は行うため、不一致の状態で検査、処
置を開始してしまう可能性は低いと考えております。万が一、異なる患者情報が表示された状態で検査、処置を
実施した場合、患者情報に異なる画像が記録されてしまう可能性があります。
しかしながら、医師は検査直後の診療記録を作成する際に、撮影した画像と、患者情報が一致しないことに気付
くこと及び臨床上の総合的診断は、他の検査情報と併せて医師によって行われるため重篤な健康被害につながる
可能性はないと考えております。なお、現在、本事象による健康被害は発生しておりません。

(2)本現象により粘膜が白く変色したとの報告を受けておりますが、医師の管理下で使用されることから、直ち
に適切な医学的処置を行うことにより重篤な健康被害には至らないと考えております。
また、これまでに本現象による患者への出血・穿孔・追加処置等が発生したという報告はございません。
なお、GIF-EZ1500、CF-EZ1500DL、CF-EZ1500DIの納入施設へは文書を配付し、使用を停止していただくようお願
いしております。

令和3年3月8日

本品は、内視鏡に照明を供給する光源と、内視鏡を介して体腔内に送気送水を行うための送気機能を有し、内視
鏡から送信された画像信号を処理し、診療のために提供することと、当社指定の内視鏡関連機器と組み合わせ
て、関連機器の機能実施、停止、動作切り替えを集中操作、集中表示をすることを目的とする。

本製品の納入施設は全て特定できておりますので、当社担当者が改修告知文を納入施設へ配付し、対象品を改修
いたします。

担当者　： QARA Safety Management
連絡先　： オリンパスメディカルシステムズ株式会社
　　　　　 東京都新宿区西新宿2-3-1　新宿モノリス
電話番号： 03-6901-4014(直通)
FAX番号 ： 03-6901-3955