AMS 700? CX TENACIO? PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100831451 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. DIFFICULT TO INFLATE, INFLATION ISSUE, SPONTANEOUS DEFLATION, FLUID LEAKAGE, AND RESERVOIR HOLE 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) PUMP WOULD NOT INFLATE OR DEFLATE. THE PUMP IS EITHER ROCK HARD OR ONCE STARTED IT IS VERY DIFFICULT TO INFLATE. THERE WAS ALSO AUTO DEFLATION ISSUES. THE PHYSICIAN ATTEMPTED TROUBLESHOOTING WITH NO SUCCESS. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT, THE PHYSICIAN NOTED BLOOD IN THE DEVICE AND THE RESERVOIR HAD A HOLE. NO ADDITIONAL INFORMATION WAS PROVIDED.