PATIENT UNDERWENT A CYSTOSCOPY FOR URETHRAL STRICTURE RELEASE. THE COLD KNIFE WAS ADVANCED THROUGH THE CYSTOSCOPE AND WHEN THE SURGEON TRIED TO USE THE KNIFE, IT BROKE IN THE PATIENT'S URETHRA. HE TRIED UNSUCCESSFULLY FOR AN HOUR TO RETRIEVE THE KNIFE UNDER FLUOROSCOPY. THE SURGEON, UPON CONSULTING WITH THE CHAIRMAN OF SURGERY AND ANOTHER UROLOGIST DETERMINED IT TO BE IN THE PATIENT'S BEST INTEREST TO LEAVE THE BLADE IN THE URETHRA. A FOLEY CATHETER WAS INSERTED INTO THE URETHRA. THE PATIENT WAS DISCHARGED WITH THE BLADE STILL INSIDE OF HIS URETHRA. HE WAS TOLD TO CONSULT WITH HIS UROLOGIST. IT IS UNKNOWN WHAT THE UROLOGIST'S PLAN OF CARE WILL BE RELATED TO THE RETAINED FOREIGN BODY.
N
Patient 1
THIS DEVICE IS BEING HELD BY THE RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL. THE FACILITY SENT US A COPY OF THE LABEL AND ALSO A PICTURE OF THE BROKEN DEVICE. ACCORDING TO THE IFU, THE DEVICE IS SINGLE USE ONLY, AND REQUIRES IT TO BE STERILIZED PRIOR TO USE. THE RISK MANAGER STATED THAT SHE DID NOT HAVE ANY INFORMATION REGARDING THE PROCESSING OF THE DEVICE PRIOR TO USE IN THE CASE OR IF IT HAD BEEN REPROCESSED PRIOR TO IT'S USE. MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.