MalfunctionFBO
UROLOGY INNER SHEATH
Received Nov 18, 2021 · Event occurred May 21, 2021
Report 9610617-2021-00078 · MDR key 12834932
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
Additional Manufacturer Narrative
PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. WE HAVE BEEN UNABLE TO OBTAIN ANY INFORMATION REGARDING THE INCIDENT FROM THE FACILITY.
Description of Event or Problem
THE DISTAL TIP OF THE SECOND SHEATH BROKE OFF INSIDE PATIENT DURING A CYSTOSCOPY.