MalfunctionOCZ
FORCEPS,OPITCAL BIOPSY, EXTRA LARGE
Received Aug 28, 2019 · Event occurred Aug 2, 2019
Report 9610617-2019-00064 · MDR key 8942020
Device
Generic name
Urology Biopsy Forceps
Manufacturer
Karl Storz Se & Co. KgModel number
27072BSACatalog number
27072BSA
Lot number
XR
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
50 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PER THE INSTRUMENT EVALUATION REPORT, THE LINKAGE ON JAWS WERE BROKEN OFF FROM THE DRAW BAR, A SMALL PIECE WAS AND IT MEASURES 0.5 X 1.1MM. THE BREAKAGE MOST LIKELY WAS FROM MECHANICAL FORCE AND THE SMALL PIECE COULD BE FLUSHED OUT WITH AN IRRIGANT.
Description of Event or Problem
ALLEGEDLY, DURING A BLADDER STONE REMOVAL (LITHOTRIPSY RETRIEVAL OF STONE), WHILE INSIDE THE PATIENT, THE JAWS OF THE GRASPER BECAME LOOSE AND THE INSTRUMENT WAS REMOVED IMMEDIATELY. DR. REPLACED THE GRASPER AND COMPLETED THE PROCEDURE.