AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) PUMP WAS NOT FUNCTIONING PROPERLY AND THAT THE DEVICE WAS EXHIBITED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A LARGE AIR BUBBLE WAS IDENTIFIED WITHIN THE ORIGINAL PUMP. ADDITIONALLY, THE PUMP WAS FOUND TO BE INVERTED AND ENCAPSULATED BY SURROUNDING TISSUE. EROSION WAS ALSO OBSERVED. THE PUMP WAS REMOVED, AND THE AIR WAS EVACUATED FROM THE SYSTEM. A NEW PUMP WAS IMPLANTED, AND THE RESERVOIR WAS REFILLED WITH FRESH SALINE. THE NEW PUMP WAS CONNECTED TO THE EXISTING SYSTEM AND TESTED MULTIPLE TIMES, DEMONSTRATING SATISFACTORY FUNCTION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100353611 MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML UNIQUE IDENTIFIER (UDI) #: (B)(4).