AMS 700 CX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404155. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0160043014. MODEL/CATALOG DESCRIPTION: RESERVOIR 65 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. FLUID LEAK IS ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND IS NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A FLUID LOSS IN THE SYSTEM. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.