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平成21年3月31日作成
一般名及び販売名
一般的名称 ：超音波プローブ用穿刺針装着器具 販売名 ：穿刺アダプタ EZU-PA5V
対象製造番号、数量及び出荷時期
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製造販売業者等名称
製造販売業者の名称 ：株式会社 日立メディコ 製造販売業者の住所 ：東京都千代田区外神田四丁目１４番１号 主たる機能を有する ：千葉県柏市新十余二２番地１ 事業所所在地 薬事の業態 ：第一種医療機器製造販売業者 製造販売業許可番号 ：12B1X00004 (1) 製造所１ ・ 製造所の名称 ：栃木精工株式会社 ・ 製造所の所在地 ：栃木県栃木市平柳町２丁目１番地５ ・ 薬事の業態 ：医療機器製造業 ・ 製造業許可番号 ：09BZ000028 (2) 製造所２ ・ 製造所の名称 ：日本照射サービス株式会社 東海センター ・ 製造所の所在地 ：茨城県那珂郡東海村大字石神外宿２６００番地 ・ 薬事の業態 ：医療機器製造業 ・ 製造業許可番号 ：08BZ005005
回収理由
国内の納入先において、当該機器を探触子上に取り付けるために滅菌袋を開封しようとした際、穿刺アダプタの 中に埋め込まれ穿刺用針のガイドとして使用するステンレスパイプ上に異物が付着している事例が確認されまし た。この際、医師は当該医療機器の使用を中止したため本事象による健康被害の発生はありませんでした。 調査の結果、穿刺アダプタの製造工程中の市水（水道水）による超音波洗浄工程の後に行われた精製水による洗 浄工程が不十分であったために、市水が残留したまま次工程以降の作業が行われ、その後の製品流通過程の途中 でステンレスパイプの表面に微細な腐食が発生し、これが異物として認識されたものであることが判明しまし た。 ステンレスパイプ上に発生する錆は微少であり、これにより重篤な健康被害が発生する可能性はまず考えられま せんが、体腔内に挿入する滅菌医療機器に異物が付着していることは製品の品質上重大な問題であるため、当該 製品を市場から回収することといたしました。
危惧される具体的な健康被害
本医療機器は医師等の有資格者により取り扱われます。また、機器の使用者に対して使用前の機器の状態を確認 することが添付文書上で求められており、異物の付着等の異常が確認された場合には機器が使用されることはあ りません。このため、本件により重篤な健康被害が発生する可能性はまず考えられません。 なお、本件による健康被害発生の報告は受けておりません。
回収開始年月日
平成21年3月26日（情報提供の開始）
効果・効能又は用途等
本機器は、超音波プローブ等に穿刺針を装着するために用いる固定用器具です。
その他
対象医療機関の名称と所在地は全て把握しておりますので、納入致しました医療機関に情報提供のうえ、当該製 品の回収を行います。
担当者及び連絡先
担当者名 ：品質保証本部 薬事情報管理部 平出博一 池谷和之 連絡先 ：株式会社 日立メディコ 柏事業場 千葉県柏市新十余二2番地1 電話 04-7131-4167 FAX 04-7131-4774