inforMED
OtherDWZ

KARL STORZ

Received May 12, 2006 · Event occurred Mar 23, 2006

Report 2020550-2006-00029 · MDR key 715030

Device

Generic name

Biopsy Forceps

Model number

28162FL

Catalog number

28162FL

Lot number

FG

Product problems

  • Detachment Of Device Component
  • Migration or Expulsion of Device
  • Material Separation
  • Tip breakage

Patient

UNKNOWN

  • Migration
  • Foreign body, removal of
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

PIECE OF BIOPSY FORCEPS CAME OFF INSTRUMENT AND LODGED IN PT'S BRAIN OR SOFT TISSUE AND WAS NOT RETRIEVED. UPON FOLLOW UP THE RISK MGR, WE LEARNED THAT THE DOCTOR DID, IN FACT, RETRIEVE THE BROKEN PIECE DURING SAME PROCEDURE. IN 2006, MRI WAS PERFORMED AND CAME BACK NEGATIVE. MRI ALSO CONFIRMED THERE WAS NO ADVERSE EFFECT ON PT DUE TO BREAKAGE. ORIGINAL PROCEDURE COMPLETED WITH NO ADVERSE EFFECT ON PT; PT CONDITION POST-OP AND LATER WHEN HE RETURNED FOR SUTURE REMOVAL WAS FINE.