INNER SHEATH FOR 27050 SL
Received May 31, 2023
Report 9610617-2023-00652 · MDR key 17031016
Device
Generic name
Inner Sheath For 27050 Sl
Manufacturer
Karl Storz Se & Co. KgModel number
27050XACatalog number
27050XA
Lot number
SU05
Product problems
- Break
- Break
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 22-0074 CORRECTIVE ACTION 12. BAJONET ON THE SHEATH IS BROKEN. METAL SHEATH SHOWS A DROP OF FOREIGN GLUE AT THE EDGE TOWARDS THE CERAMICS. THE SHEATH SHOWS A THIRD PARTY LASER MARKING. THE FINISH OF THE SHEATH IS NOT ACCORDING TO KARL STORZ SPECIFICATION (AXIAL GRINDING SCRATCHES). HENCE, IT WAS MOST LIKELY THIRD PARTY REPAIR, WHERE THE CERAMIC TIP GOT A PRE-DAMAGE THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A CERAMIC BEAK ON TIP OF RESECTION SHEATH BROKE INTO SEVERAL PIECES WHILST IN USE WITHIN THE PATIENTS BLADDER. NO FURTHER INFORMATION AVAILABLE.