inforMED
MalfunctionKNW

PRIMED INSTRUMENTATION INC

Received Mar 26, 2002 · Event occurred Mar 21, 2002

Report 385011 · MDR key 385011

Device

Generic name

Endoscopic Biopsy Forcep

Model number

UNK

Catalog number

UNK

Lot number

UNK

Product problems

  • Component(s), broken
  • Detachment Of Device Component
  • Device, or device fragments remain in patient

Patient

76 YR

  • Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

PT WAS UNDERGOING AN UPPER GI ENDOSCOPY IN THE GI LAB. ONE HALF OF AN ENDOSCOPY BIOPSY FORCEP CUP BROKE OFF DURING THE PROCEDURE AND REMAINED IN PT. THE SMALL BIOPSY CUP COULD NOT BE RETRIEVED. PT WAS INFORMED THAT PT WOULD PASS IT. NO KNOWN PT ADVERSE OUTCOME AT THIS TIME.