AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO INFLATE THE DEVICE. UPON INSPECTION, A RIGHT SIDED CORPORAL ANEURYSM WAS IDENTIFIED. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED, WHILE THE RESERVOIR WAS LEFT IN PLACE. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED. THEREFORE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION. MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100435085. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).