MalfunctionFBO
INNER SHEATH
Received Mar 1, 2018 · Event occurred Jan 19, 2018
Report 9610617-2018-00019 · MDR key 7308576
Device
Product problems
- Material Separation
- Material Separation
Patient
92 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INNER SHEATH WAS NOT RETURNED TO KARL STORZ FOR EVALUATION.
Description of Event or Problem
ALLEGEDLY, DURING A PHOTOSELECTIVE VAPORIZATION OF PROSTATE (PVP) PROCEDURE, A PIECE OF THE CERAMIC BEAK ON RESECTOSCOPE INNER SHEATH BROKE OFF INSIDE THE PATIENT'S BLADDER AND WAS RETRIEVED. DOCTOR PERFORMED BLADDER IRRIGATION POST-OP AND NOTHING WAS FOUND; X-RAY IN THE POST-ANETHESIA CARE UNIT WAS NEGATIVE. THE HOSPITAL REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.