MalfunctionFBO
UROLOGY INNER SHEATH
Received Mar 22, 2021 · Event occurred Feb 26, 2021
Report 9610617-2021-00034 · MDR key 11546117
Device
Generic name
Inner Resectoscope Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
NP
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- Unspecified Kidney or Urinary Problem
- Unspecified Kidney or Urinary Problem
Narrative
Additional Manufacturer Narrative
PRODUCT HAS BEEN RETURNED BUT NOT EVALUATED. ONCE EVALUATED A SUPPLEMENTAL FILLING IF NECESSARY, MAY BE SUBMITTED.
Description of Event or Problem
THE DISTAL TIP OF SHEATH BROKE OFF DURING A PROCEDURE. WE HAVE NOT RECEIVED ANY INFORMATION REGARDING THE INCIDENT FROM THE FACILITY.