MalfunctionFBO
UROLOGY INNER SHEATH
Received Jul 21, 2022 · Event occurred Jun 22, 2022
Report 9610617-2022-00124 · MDR key 15075501
Device
Generic name
Inner Resectoscope Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
WO02
Product problems
- Material Separation
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT EVALUATION FINDINGS "CERAMIC TIP BROKE OFF FROM THE DISTAL END AND SHAFT IS BENT INDICATING FORCE APPLIED IN EVIDENCE OF USE". WE HAVE BEEN UNABLE TO OBTAIN ANY INFORMATION REGARDING THE INCIDENT FROM THE FACILITY.
Description of Event or Problem
THE CERAMIC DISTAL TIP OF THE SHEATH BROKE OFF INSIDE PATIENT IN ONE PIECE DURING A PROCEDURE.