KNIFE, STRAIGHT
Received Jan 30, 2026 · Event occurred Jan 6, 2026
Report 9610617-2026-00176 · MDR key 24225423
Device
Generic name
Knife, Straight
Manufacturer
Karl Storz Se & Co. KgModel number
27068KCatalog number
27068K
Lot number
BT2
Product problems
- Fire
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THE INSTRUMENT MALFUNCTION DURING USE. THE INCIDENT OCCURRED IN WHICH THE DEVICE FRACTURED, HOWEVER, IT REMAINS UNCLEAR AT WHICH STAGE AND AT WHAT EXACT TIME THE BREAKAGE TOOK PLACE. AS A PRECAUTIONARY MEASURE, AND TO ENSURE THAT NO FRAGMENTS REMAINED IN THE PATIENT'S BODY, AN X-RAY, A CT SCAN, AND AN ADDITIONAL CYSTOSCOPY WERE PERFORMED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. 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).