AMS 700 LGX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGICAL IMPLANTATION PROCEDURE OF AN INFLATABLE PENILE PROSTHESIS (IPP), AN ISSUE WAS IDENTIFIED DURING DEVICE PREPARATION. THE DEVICE DID NOT INFLATE PROPERLY AND EXHIBITED A SIGNIFICANT DELAY IN RECOIL. THE DEVICE WAS EVENTUALLY PREPARED; HOWEVER, ADDITIONAL ISSUES WERE NOTED INTRAOPERATIVELY. AFTER INSERTION AND TEST INFLATION, THE DEVICE DID NOT DEFLATE. THE EXPECTED DEFLATION "BUZZ" WAS NOT OBSERVED AND CONTINUED TO DEMONSTRATE VERY SLOW RECOIL DURING INFLATION. THE DEVICE WAS CYCLED APPROXIMATELY TEN TIMES WITH NO IMPROVEMENT, AND MULTIPLE TROUBLESHOOTING TECHNIQUES WERE ATTEMPTED, INCLUDING SQUEEZING THE PUMP BLOCK; HOWEVER, THE ISSUE PERSISTED. AS A RESULT, THE DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. AN ALTERNATIVE DEVICE WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED.