inforMED
MalfunctionOCZ

FORCEPS,MINIATURE ALLIGATOR

Received Jan 13, 2021 · Event occurred Nov 1, 2020

Report 9610617-2021-00010 · MDR key 11167610

Device

Generic name

Alligator Forceps

Model number

27071TJ

Lot number

OP01

Product problems

  • Material Integrity Problem
  • Material Integrity Problem

Patient

Not reported

  • Foreign Body In Patient
  • Patient Problem/Medical Problem
  • Foreign Body In Patient
  • Patient Problem/Medical Problem

Narrative

Additional Manufacturer Narrative

WE HAVE NOT RECEIVED CONFIRMATION FROM OUR CUSTOMER IF THEY WILL RETURN THE ITEM FOR FURTHER EVALUATION. IF THE ITEM RETURNS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

PER MEDWATCH REPORT # (B)(4) RECIEVED, THE GRASPER BROKE DURING FIRST ATTEMPT TO GRASP A URETERAL STENT. THE PIECE OF JAW THAT BROKE OFF WAS RETRIEVED AND REMOVED FROM THE PATIENT.