AMS 700 MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404013, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1000128110, MODEL/CATALOG DESCRIPTION: CXR 16CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404161, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1000174141, MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC, UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE PUMP CONNECTING TUBE WAS IDENTIFIED. THE PUMP WAS REMOVED AND REPLACED. THE CAUSE OF CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.