INNER SHEATH WITH CERAMIC BEAK
Received Mar 2, 2019 · Event occurred Nov 9, 2018
Report 9610617-2019-00026 · MDR key 8384584
Device
Generic name
Inner Resectoscope Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
TS04
Product problems
- Material Separation
- Material Separation
Patient
77 YR
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED. THE CERAMIC TIP WAS BROKEN OFF. DAMAGE IS MOST LIKELY DUE TO THE CERAMIC BEAK MAKING CONTACT WITH A HARD SURFACE, CAUSING AN INTERNAL CRACK AND RESULTING IN THE BREAKAGE; WE CANNOT CONFIRM.
Description of Event or Problem
ALLEGEDLY, DURING A TURP PROCEDURE, THE CERAMIC TIP OF THE SHEATH BROKE OFF INTO THE PATIENT. THEY WERE UNABLE TO QUICKLY RETRIEVE THE BROKEN PIECE AND, DUE TO PATIENT'S EXCESSIVE BLEEDING, THEY DECIDED TO WAIT UNTIL BLEEDING STOPPED TO PERFORM A SUBSEQUENT PROCEDURE TO RETRIEVE THE PIECE, WHICH WAS PERFORMED FOUR DAYS LATER. THERE WAS NO HARM TO PATIENT.