InjuryPKL
PADLOCK CLIP DEVICE
Received Jul 28, 2025
Report MW5173427 · MDR key 22633296
Device
Generic name
Hemostatic Metal Clip For The Gi Tract
Manufacturer
Isomedix Operations Inc./steris CorporationProduct problems
- Failure to Fire
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING PROCEDURE THE PADLOCK CLIP DEVICE WAS CORRECTLY PLACED ON THE ENDOSCOPE. AT THE MOMENT OF RELEASE, THE HANDLE MAKES A 'CLICK' SOUND, BUT THE CLIP IS NOT RELEASED. IT WAS NECESSARY TO REMOVE THE ENDOSCOPE, PUT IT IN ANOTHER DEVICE, AND START AGAIN, ALL DURING ACTIVE HEMORRHAGE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).