MalfunctionFBO
UROLOGY INNER SHEATH
Received Jul 1, 2022 · Event occurred Jun 1, 2022
Report 9610617-2021-00101 · MDR key 14886306
Device
Generic name
Inner Resectoscope Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
ZP01
Product problems
- Material Separation
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PER FACILITY DURING A PROCEDURE THE DISTAL CERAMIC TIP OF THE INNER SHEATH BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. NO ADDITIONAL INFORMATION PROVIDED.
Additional Manufacturer Narrative
PRODUCT HAS BEEN RETURNED FOR EVALUATION HOWEVER; EVALUATION HAS NOT BEEN COMPLETED.