MalfunctionFBO
UROLOGY INNER SHEATH
Received Nov 7, 2022 · Event occurred Oct 11, 2022
Report 2020550-2022-00296 · MDR key 15748900
Device
Generic name
Inner Resectoscope Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
XR02
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED FOR EVALUATION BY THE FACILITY, THEREFORE; NO EVALUATION CAUSE OR FINDINGS CAN BE OBTAINED.
Description of Event or Problem
THE MANUFACTURES REFERENCE NUMBER IS (B)(4). THE INSTRUMENT BROKE INSIDE THE PATIENT DURING A PROCEDURE. THE SURGEON WAS ABLE TO RETRIEVE THE INSTRUMENT FROM THE PATIENT AND THE PATIENT DID NOT SUFFER ANY TRAUMA. IT HAPPENED TOWARDS THE END OF THE PROCEDURE SO THERE WAS ONLY A DELAYED OF APPROXIMATELY 5 MINUTES.