MalfunctionFBO
UROLOGY INNER SHEATH
Received Nov 17, 2021 · Event occurred May 21, 2021
Report 9610617-2021-00077 · MDR key 12827705
Device
Generic name
Inner Resectoscope Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
WS03
Product problems
- Material Separation
- Material Separation
Patient
Male
- Unspecified Kidney or Urinary Problem
- Unspecified Kidney or Urinary Problem
Narrative
Description of Event or Problem
THE DISTAL TIP OF SHEATH BROKE OFF INSIDE PATIENT DURING A CYSTOSCOPY.
Additional Manufacturer Narrative
PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. WE HAVE BEEN UNABLE TO OBTAIN ANY INFORMATION REGARDING THE INCIDENT FROM THE FACILITY.