MalfunctionFBO
INNER SHEATH WITH CERAMIC BEAK
Received Aug 20, 2020 · Event occurred Jun 11, 2020
Report 9610617-2020-00093 · MDR key 10432051
Device
Generic name
Resectoscope Inner Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOT NUMBER IS TQ06 (MANUFACTURE DATE: 06/2019). MOST LIKELY CAUSE OF THIS TYPE OF BREAKAGE IS MECHANICAL DAMAGE.
Description of Event or Problem
ALLEGEDLY, PIECES OF THE INNER TUBE'S CERAMIC BEAK BROKE OFF INTO THE PATIENT DURING A CYSTO URETEROSCOPY PROCEDURE. THE BROKEN PIECES WERE RETRIEVED, AND CUSTOMER CONFIRMED THERE WAS NO HARM TO PATIENT.