AMS 700 LGX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404161. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100757488. MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC. 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. HOLE AND FLUID LEAKAGE ARE ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND IS NOT RELATED TO OFF LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. 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 A MICROPUNCTURE AND FLUID LEAKAGE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE CYLINDER AND PUMP WERE EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.