MalfunctionOCZ
STERIS RAPTOR GRASPING DEVICE
Received Oct 1, 2021
Report MW5104340 · MDR key 12568850
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Model number
00711177Lot number
2108246
Product problems
- Activation, Positioning or Separation Problem
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ALLIGATOR GRASP MALFUNCTIONED WHILE USING IT IN THE PATIENT TRYING TO GRASP THE STENT [INVALID] THEY WERE UNABLE TO CONTINUE TO USE THE DEVICE OR PULL THE STENT OUT. THEY NEEDED TO CUT THE WIRE AND LEAVE THE DEVICE ATTACHED TO THE STENT AND DEPLOY ANOTHER GRASPER TO GRAB THE STENT AND THE GRASPER. FDA SAFETY REPORT ID # (B)(4).