INNER SHEATH FOR 27050 SC
Received May 2, 2024 · Event occurred Mar 1, 2024
Report 2020550-2024-00127 · MDR key 19231153
Device
Generic name
Endoscope Sheath, Reusable
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
XT06
Product problems
- Break
- Break
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A FRACTURE/DETACHMENT OF THE CERAMIC TIP FROM THE SLEEVE OF THE RESECTOR DURING THE PATIENT'S PROCEDURE. FIRST INTERVENTION ON (B)(6) 2023 FOR A HOLEP, AND RE-INTERVENTION OF THE PATIENT IN (B)(6) 2024, AS A CERAMIC TIP BROKE OFF AND REMAINED IN THE PATIENT'S BLADDER, REQUIRING FOREIGN BODY REMOVAL.
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID:(B)(4).