AMS 700 LGX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01, BATCH/LOT NUMBER: 1100857163, MODEL/CATALOG DESCRIPTION: RESERVOIR, 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 THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD FLUID LOSS. UPON INSPECTION A BUBBLE IN THE PUMP WAS NOTICED. AS A RESULT, THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.