CYSTOSCOPE SHEATH, 17 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 THE FOLLOWING: "WHILE PERFORMING A BLADDER NECK STRICTURE INCISION FOR A 72-YEAR-OLD MALE PATIENT WITH A PREVIOUS RADICAL PROSTATECTOMY FOR PROSTATE CANCER AND A RESULTING BLADDER NECK STRICTURE, WE DOCUMENTED A MAJOR 17-FRENCH CYSTOSCOPE MALFUNCTION AND A RESULTING FOREIGN BODY THAT WAS RETRIEVED FROM THE BLADDER USING A 22-FRENCH SCOPE AND ALLIGATOR FORCEPS." 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. BASED ON THE EVENT DESCRIPTION THE MOST PROBABLE AFFECTED ARTICLE WAS DETERMINED. BESIDE ARTICLE 27026UA ALSO THE ARTICLE NUMBER 27026U WOULD BE POSSIBLE.