CYSTOSCOPE SHEATH, 22 FR.

Description of Event or Problem

IT WAS REPORTED THAT THE SHEATH WAS USED FOR A CYSTOSCOPY ON A PATIENT AND PART OF THE SHEATH HAS BROKEN OFF INSIDE THE PATIENT. UNFORTUNATELY, THEY HAVE BEEN UNABLE TO RETRIEVE THE MISSING PART OF THE SHEATH. X-RAY OF BLADDER SHOWED THAT A 2CM (APPROX) END OF THE CYSTOSCOPE SHEATH HAD SNAPPED OFF AND WAS IN THE BLADDER. SURGEON DECIDED THAT THE BEST ACTION WAS TO PLACE A 22FR 3 WAY CATHETER AND LET THE BLADDER HEAL. THE PATIENT WAS TRANSFERRED TO RECOVERY AND THEN RETURNED TO THE WARD WITH A PLAN FOR IRRIGATION OVERNIGHT, THEN HOME IN THE MORNING. UNFORTUNATELY, DURING THE NIGHT, THE PATIENT BECAME UNWELL AND REQUIRED TRANSFERRING TO (B)(6). PATIENT WILL NEED SURGERY WITHIN 5-6 WEEKS AFTER THE BLADDER HAS HEALED, IN ORDER TO REMOVE THE 2CM PIECE OF METAL CYSTOSCOPE. DUE TO A DETACHED PART BEING LEFT INSIDE THE PATIENT AND THE NECESSITY OF AN ADDITIONAL INTERVENTION FOR ITS REMOVAL, THIS CASE IS DEEMED REPORTABLE.

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).