AMS 700 CXR

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404310, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 0136556003, MODEL/CATALOG DESCRIPTION: PUMP MS, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404161, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 0135572003, MODEL/CATALOG DESCRIPTION: RESERVOIR 65 ML PC, 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) WAS NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH IT WAS IDENTIFIED THAT THE RIGHT CYLINDER HAD A BULGE. BOTH CYLINDERS AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.