MalfunctionFBO
INNER SHEATH FOR 27050 SC
Received Jul 9, 2025 · Event occurred Jun 15, 2025
Report 9610617-2025-01184 · MDR key 22459879
Device
Generic name
Inner Sheath For 27050 Sc
Manufacturer
Karl Storz Se & Co. KgModel number
R27050CACatalog number
R27050CA
Lot number
SN11
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT CERAMIC TIP BROKE OFF DURING THE PROCEDURE. THEY HAD TO OPEN ANOTHER TRAY AND DELAYED THE CASE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.