MalfunctionGDY
SPONGES
Received Sep 24, 2015 · Event occurred Jun 8, 2015
Report 5100447 · MDR key 5100447
Device
Product problems
- Short Fill
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE LAP CHOLECYSTECTOMY PACK HAD 11 SPONGES. IT WAS FOUND TO BE INCORRECT AT RELIEF COUNT DURING THE PROCEDURE. THIS REQUIRED A POST-OP X-RAY, WHICH WAS NEGATIVE. THIS COULD HAVE RESULTED IN A RETAINED SPONGE.