Olympus Corporation of the Americas: Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B

Hazard

Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

Details from the source

Reason for recall: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure. Distribution: US Nationwide distribution. Quantity: 3795 pieces Lot/code info: UDI-DI: 04953170385940 Lot Numbers: 24K, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK

UPC codes

04953170385940

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.