AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. THE PATIENT WAS UNABLE TO ACHIEVE MAXIMUM RIGIDITY, AS THE VALVE WOULD RELEASE PREMATURELY, RESULTING IN DEFLATION OF THE IMPLANT. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. 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: 72404156 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100743459 MODEL/CATALOG DESCRIPTION: RESERVOIR 100 ML PC/IZ UNIQUE IDENTIFIER (UDI) # (B)(4).