MalfunctionFBO
INNER TUBE WITH CERAMIC BEAK
Received Apr 13, 2018 · Event occurred Apr 10, 2018
Report 7428297 · MDR key 7428297
Device
Generic name
Cystourethroscope
Manufacturer
Karl Storz Gmbh Co. KgModel number
27050XACatalog number
27050XA
Lot number
SW06
Product problems
- Break
- Detachment Of Device Component
- Crack
Patient
66 YR
- No Information
- No Information
Narrative
Description of Event or Problem
PATIENT WAS IN THE OPERATING ROOM (OR) FOR A CYSTOSCOPY AND TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). INNER SHEATH OF KARL STORZ INSTRUMENT HAD THE TIP COVERED IN PLASTIC. PLASTIC CRACKED AND PIECES OF PLASTIC BROKE OFF INTO THE PATIENT BLADDER. DR. IRRIGATED AND USED GRASPERS TO RETRIEVE THE PIECES OF PLASTIC. HE IRRIGATED THE BLADDER COPIOUSLY AND INSPECTED THE BLADDER THOROUGHLY UNDER VIDEO ENDOSCOPY TO ENSURE NO PIECES WERE LEFT IN THE BLADDER.