inforMED
MalfunctionOCZ

OPTICAL BIOPSY FORCEPS

Received Nov 24, 2020 · Event occurred Oct 27, 2020

Report 9610617-2020-00132 · MDR key 10891272

Device

Generic name

Optical Grasping Forceps

Model number

27072A

Catalog number

27072A

Lot number

VR

Product problems

  • Connection Problem
  • Connection Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE INSTRUMENT HAS A BROKEN DRAWBAR LINKAGE AND INDENTATION ON THE JAW. THE INSTRUMENT IS OVER 2 YEARS OLD AND SHOWS SIGN OF LONG USAGES.

Description of Event or Problem

ALLEGEDLY, PER THE CUSTOMER DURING A UROLOGY PROCEDURE A SCREW OR RIVET ON THE JAW BROKE OFF IN THE PATIENTS BLADDER. THE PIECE WAS RETRIEVED, THE PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTION REQUIRED OR HARM TO THE PATIENT.