INNER SHEATH FOR 27050 SC
Received Oct 19, 2023 · Event occurred Feb 1, 2021
Report 9610617-2023-00301 · MDR key 17970225
Device
Generic name
Inner Sheath For 27050 Sc
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PART OF THE DEVICE BROKE OFF DURING SURGICAL PROCEDURE. SURGEON RETRIEVED THE BROKEN PART, NO HARM TO THE PATIENT.
Additional Manufacturer Narrative
THE PREVIOUS REPORTABILITY DECISION FOR THIS EVENT WAS REVERSED BASED ON A RETROSPECTIVE REVIEW. THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS RETURNED FOR INVESTIGATION. INVESTIGATION FINDINGS: BROKEN CERAMIC BEAK AND SCRATCHED, DISTAL END IS DENTED WITH BURRS WHERE THE BEAK ONCE WAS. THE SHAFT IS SEVERELY SCRATCHED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).