AMS 700 CX MS Pump

Description of Event or Problem

IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A BROKEN TUBING FROM THE PUMP RESERVOIR WAS IDENTIFIED; AS A RESULT, THE PUMP WAS REMOVED AND REPLACED. THE CAUSE OF THE FLUID LOSS WAS ATTRIBUTED TO THE BROKEN TUBE. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404155 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100804757 MODEL/CATALOG DESCRIPTION: RESERVOIR 65 ML PC/IZ UNIQUE IDENTIFIER (UDI) #: (B)(4).