Generic Name: Endoscopic Active Resection Device — Trade Name: Quanta Cyber Blade Morcellator
- Recalling firm
- Name of Manufacturer and Distributor: Edapp TechnoMed Co., Ltd. — Address of Manufacturer and Distributor: 4th Floor, Hakozaki Regent Building, 17-1 Nihonbashi Hakozaki-cho, Chuo-ku, Tokyo (*) —...
- Product
- Lot: 対象製造ロット番号：FF01065 数量：60 出荷時期：令和7年3月〜令和7年4月. Use: 内視鏡使用下で体腔内に挿入し、組織の切除に用いる. Health hazards: 本不具合により、手術時間の延長が発生するおそれがあります。 しかしながら、当該医療機器は医療従事者が使用するものであり、適切な処置を行うことで、患者に傷害を発生 させる等の重篤な健康被害に至るおそれはないと考えられます。 現在までに当該事象に係る健康被害の報告はありません。
- Reason
- We have received reports from several medical facilities in Japan that the devices are unable to aspirate tissue. Upon inspecting the defective units returned to us, we confirmed that there was a manufacturing defect in the assembly of internal components. Since all reported defective products belong to the same manufacturing lot, and we cannot rule out the possibility of similar defects occurring within that lot, we are conducting a voluntary recall.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/db063858-ef04-4354-bfb6-09c606411e9f