CYSTO-URETHRO-FIBERSCOPE
Received Aug 22, 2025
Report 1221826-2025-01461 · MDR key 22873171
Device
Generic name
Cysto-urethro-fiberscope
Manufacturer
Karl Storz Endovision IncModel number
11272C1Catalog number
11272C1
Lot number
2098132
Product problems
- Mechanical Problem
- Adverse Event Without Identified Device or Use Problem
- Mechanical Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Bowel Perforation
- Bowel Perforation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE FLEX IS LEAKING. BLADDER INJURY, UNNOTICED EMPTYING OF THE BLADDER.
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative
INVESTIGATION WAS CLOSED ON SEPTEMBER 22, 2025. THE FOLLOWING WAS FOUND: A VISUAL AND FUNCTIONAL TEST WAS CARRIED OUT ON THE ENDOSCOPE. THE ENDOSCOPE SHOWS SIGNS OF USE (SCRATCHES), THE STOPCOCK DRIVER ON THE STOPCOCK HOUSING AND THE LIGHT CONNECTION ADAPTER ARE MISSING. THERE ARE STAINS ON THE COVER GLASS. THERE ARE STAINS ON THE COVER GLASS AND THE STOPCOCK HOUSING IS CORRODED. THE SHAFT AND THE ARTICULATION COVER ARE DAMAGED AND THEREFORE LEAKY. THE CAUSES OF THESE PROBLEMS ARE DUE TO USAGE ERRORS OR/AND WEAR. THE ENDOSCOPE MAY NO LONGER BE USED IN THIS CONDITION AND MUST BE REPAIRED. THE ERROR DESCRIBED BY THE CUSTOMER "INJURY TO THE BLADDER, UNNOTICED EMPTYING OF THE BLADDER" BY THE ENDOSCOPE COULD NOT BE CONFIRMED. THE DISTAL END AND THE ARTICULATION COVER HAVE NO SHARP-EDGED DAMAGE THAT COULD HAVE LED TO DAMAGE TO THE BLADDER. ALL EDGES ARE ROUNDED AND THE DAMAGE FOUND IN THESE AREAS WOULD NOT DAMAGE THE BLADDER. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).