AMS 700? CX TENACIO? PUMP

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: 1100650920. MODEL/CATALOG DESCRIPTION: RESERVOIR. UNIQUE IDENTIFIER (UDI) # (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) DIFFICULTY OPERATING THE PUMP, DEFLATING AND INFLATING, RESULTING IN PAIN AND DISCOMFORT IN THE SCROTUM. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED, WHILE THE RESERVOIR WAS RETAINED AND REUSED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.