CYSTOSCOPE SHEATH, 22 FR.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE REPORTED EVENT WAS RETRIEVED FROM AN ARTICLE THAT WAS PUBLISHED. THE AUTHORS DESCRIBE AN UNUSUAL CASE OF CYSTOSCOPE DAMAGE DURING A PLANNED LASER CYSTOLITHOTRIPSY IN A 65-YEAR-OLD MALE WITH A PREVIOUS HISTORY OF RADICAL PROSTATECTOMY FOR PROSTATE CANCER AND SUBSEQUENT SERIAL URETHRAL DILATIONS FOR BLADDER NECK CONTRACTURE. UPON CROSSING THE PENILE URETHRA WITHOUT EXERTING SIGNIFICANT PRESSURE, THEY NOTICED THE CYSTOSCOPE'S DISTAL METALLIC TIP DETACHMENT. THEREFORE, THEY REINTRODUCED ANOTHER 22FR CYSTOSCOPE AND REMOVED THE BROKEN PART WITH ALLIGATOR FORCEPS. NO URETHRAL INJURY OR ASSOCIATED COMPLICATIONS WERE NOTICED ON GENTLY RE-ENTERING THE BLADDER. THE ENDOSCOPIC LASER CYSTOLITHOTRIPSY WAS COMPLETED SUCCESSFULLY SHORTLY THEREAFTER. WE MUST POINT OUT THAT, DUE TO THE SOURCE OF THE INFORMATION, THE FOLLOWING DETAILS ARE NOT KNOWN AND CAN BE ONLY BE ASSUMED FROM THE EVENT DESCRIPTION. THERE IS NO INFORMATION ON THE EVENT DATE. THE COUNTRY OF OCCURRENCE IS NOT CONFIRMED. BASED ON THE EVENT DESCRIPTION THE MOST PROBABLE AFFECTED ARTICLE WAS DETERMINED. BESIDE ARTICLE 27026BB ALSO THE ARTICLE NUMBERS 27026BA AND 27026B WOULD BE POSSIBLE.