inforMED
InjuryGAF

STORZ

Received Mar 17, 1997 · Event occurred Feb 28, 1997

Report 77480 · MDR key 77480

Device

Generic name

Endoscopic Spatula

Model number

30873B

Catalog number

*

Lot number

*

Product problems

  • Break

Patient

34 YR

  • Surgery, prolonged
  • Foreign body, removal of

Narrative

Description of Event or Problem

PT IN MAJOR SURGERY FOR A LAPAROSCOPIC CHOLECYSTECTOMY. SURGEIN USING SPATULA TO SEPARATE GALL BLADDER FROM THE LIVER BED. THE END OF THE SPATULA SNAPPED OFF AND WENT INTO THE BODY CAVITY. FLUROSCOPY WAS USED TO LOCATE AND RETRIEVE BROKEN PIECE. INSPECTION DONE, NO OTHER PIECES MISSING. APPROX 30-45 MINUTES OF EXTRA SURGERY AND ANESTHESIA TIME. THE MFR WAS NOTIFIED THE SAME DAY.