INNER TUBE WITH CERAMIC BEAK
Received Mar 7, 2018 · Event occurred Feb 7, 2018
Report 9610617-2018-00021 · MDR key 7322439
Device
Generic name
Inner Tube With Ceramic Beak
Manufacturer
Karl Storz Se & Co. KgModel number
27050XACatalog number
27050XA
Lot number
NT
Product problems
- Material Separation
- Material Separation
Patient
69 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SHEATH HAS NOT YET RETURNED TO KARL STORZ FOR EVALUATION.
Description of Event or Problem
ALLEGEDLY, DURING A TURP PROCEDURE, THE CERAMIC TIP OF RESECTOSCOPE SHEATH BROKE OFF INSIDE THE PATIENT'S BLADDER. THE DOCTOR RETRIEVED THE BROKEN PIECE AND COMPLETED THE PROCEDURE. THE PHYSICIAN IS CONFIDENT THAT HE REMOVED ALL THE FRAGMENTS FROM THE PATIENT. PATIENT IS IN STABLE CONDITION AND DOING FINE.
Additional Manufacturer Narrative
THE SHEATH WAS EVALUATED . THE CERAMIC BEAK IS BROKEN OFF, AND THE SHAFT IS DENTED. DAMAGE IS MOST LIKELY DUE TO THE CERAMIC BEAK MAKING CONTACT WITH A HARD SURFACE CAUSING AN INTERNAL CRACK AND RESULTING IN BREAKAGE; WE CANNONT CONFIRM.