AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO FULLY AND PROPERLY DEFLATE THE DEVICE, THERE WAS A MECHANICAL ISSUE. A SURGICAL PROCEDURE WAS PERFORMED AND UPON REMOVAL FLUID IN THE SYSTEM WAS NOTED. THE DEVICE WAS THEN REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000120857. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. 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.