Device product
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Z-1988-2023
Product summary
- Event
- Event 92325
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 45 pieces
- Official record key
device-enforcement:Z-1988-2023
Official wording
Reason: 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.
Code information: UDI-DI: 04953170385926 Lot Numbers: 24K, 26K, 27K, 29K, 2XK, 2YK
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.