AMS 700 CX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100031370. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. 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. DEFLATION ISSUE 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 THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD A DEFLATION ISSUE. A SURGICAL REVISION/REPLACEMENT PROCEDURE WAS PLANNED AS THE NEXT COURSE OF ACTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.