Generic Name: Sheath For Endoscope Trade Name: Sheath Set For Continuous Irrigation Cystourethroscopy
- Recalling firm
- Name of manufacturer: Olympus Medical Systems Corporation Hachioji Office Location of manufacturer: 2951 Ishikawa-machi, Hachioji-shi, Tokyo Type of license: Type 1 medical device manufacturer...
- Product
- Lot: 型番：WA22810A 対象ロット番号 103W 104W 105W 10XW 113W 115W 11XW 125W 127W 128W 12YW 134W 138W 13XW 149W 162W 167W 16YW 176W 178W 17YW 17ZW 182W 185W 186W 189W 191W 194W 195W 197W 198W 199W 19ZW 20201 20301 20901 20X01 21201 21301 21501 21801 21X01 22201 22301 22701 22801 22901 22X02 22Z01 23502 23503 数量 170セット 出荷時期 平成19年10月18日 ～ 令和06年07月20日. Use: 本品は、鏡視下にて処置具の挿入と持続的な灌流を行うことを目的とする。. Health hazards: グリーンライトレーザーと組み合わせ使用する場合に起こりうる健康上のリスクとして、シース先端の損傷や過 熱が生じる可能性があります。シース先端が損傷した場合、処置前または処置中に機器を交換する必要がありま す。損傷したシースを使用し続けた場合、患者体内の組織の損傷や、シースの破片の脱落が発生して異物除去の...
- Reason
- We have received a report that the tip of the WA22810A perfusion sheath 22.5Fr. (hereinafter referred to as "the device") was damaged during a surgery using the GreenLight laser in combination with the device. In investigating these reports, we discovered that there is a lack of evidence to guarantee the compatibility of the combination with the GreenLight laser. We have been re-examining the compatibility of the GreenLight laser combination and have discovered that we need to comply with the latest laws and regulations in order to guarantee the compatibility of the device.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Recall date
- 2026-03-04
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/fe285e4c-0b3e-4821-8843-e93c658e37a5