AMS 700 LGX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404156, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 0178950001, MODEL/CATALOG DESCRIPTION: RESERVOIR 100 ML PC/IZ, 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. 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 THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH IT WAS IDENTIFIED A FLUID LOSS DUE TO A TUBING DISCONNECTION AND BOTH CYLINDERS RUPTURED REPORTED FROM WEAR AND TEAR. THE IPP WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.