FDA-Device2023-06-28Class II
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Olympus Corporation of the Americas
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.
Sold states
US Nationwide distribution.
Affected count
45 pieces
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1988-2023Don't want to check this manually?
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