AMS 700 LGX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT DURING THE TEST PERIOD, ONE OF THE CYLINDERS OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT DEFLATE. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL; THEREFORE, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

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. INCOMPLETE INFLATION/DEFLATION ARE ACKNOWLEDGED WITHIN THE DIRECTIONS FOR USE (DFU) AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. A RISK REVIEW WAS COMPLETED, AND DEFLATION ISSUES ARE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. 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.