AMS 700 MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404161 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100673081 MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404014 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100575759 MODEL/CATALOG DESCRIPTION: CXR 18CM UNIQUE IDENTIFIER (UDI) #: (B)(4). 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. DIFFICULT TO INFLATE IS ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND IS NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. 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.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH DIFFICULTY ACTIVATING THE DEVICE. A REVISION SURGERY WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS.