MalfunctionFXM
*
Received Jun 19, 2013 · Event occurred Jun 12, 2013
Report 3208647 · MDR key 3208647
Device
Generic name
Camera, Still, Endoscopic
Manufacturer
Karl Storz EndoscopyModel number
22220053Catalog number
*
Lot number
*
Product problems
- Break
Patient
66 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PATIENT HAVING SURGERY FOR A CABG WITH ENDOSCOPIC SAPHENOUS VEIN HARVESTING FROM BOTH LEGS. THE PA WAS USING THE CAMERA AND IT BROKE. THE RINGS OF THE CAMERA BROKE INTO PIECES. ATTEMPTED TO RECREATE THE CAMERA, BUT NOT SURE IF ALL THE PIECES AND SCREWS WERE RETRIEVED. X-RAYS OF BOTH LEGS TAKEN WERE NEGATIVE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VISUALIZATION OF THE SAPHENOUS VEIN FOR HARVESTING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.