INNER SHEATH FOR 27050 SC
Received Oct 23, 2023 · Event occurred Aug 31, 2021
Report 9610617-2023-00309 · MDR key 17989931
Device
Generic name
Inner Sheath For 27050 Sc
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Product problems
- Separation Problem
- Separation Problem
Patient
72 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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. EVALUATION FINDINGS: BROKEN CERAMIC TIP, GOUGED PROXIMAL LIP, GOUGED PROXIMAL SHAFT CONNECTION, SCRATCHED SHAFT AND WORN SEAL. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID:(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE CERAMIC TIP/BEAK BROKE OFF DURING THE PROCEDURE, DID NOT FALL INTO THE PATIENT. NO HARM TO THE PATIENT.