UROLOGY INNER SHEATH
Received Jun 27, 2023 · Event occurred May 25, 2023
Report 2020550-2023-00135 · MDR key 17213291
Device
Generic name
Inner Resectoscope Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
TQ06
Product problems
- Break
- Detachment of Device or Device Component
- Break
- Detachment of Device or Device Component
Patient
69 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH A 27050CA INNER SHEATH FOR 27050SC. ACCORDING TO THE INFORMATION RECEIVED, THE CERAMIC BEAK BROKE INSIDE PATIENTS BLADDER DURING A TURP PROCEDURE. THE PIECE/PIECES WERE ABLE TO BE REMOVED WITH NO DIRECT HARM TO PATIENT, HOWEVER; AN ADDITIONAL 30 MINUTES OF ANESTHESIA WAS ADDED TO THE PROCEDURE. IT WAS NOTED THE POSSIBILITY OF A 3RD PARTY REPAIR WAS OBSERVED BY SE.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: THE CERAMIC DISTAL TIP IS BROKEN/FRACTURED WITH REMAINING ATTACHED BEAK HAVING SHARP, JAGGED EDGE. LOT CODE IS TQ 06((06/2019). SHOULD RELEVANT ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).