AMS 700 LGX TENACIO PUMP

Description of Event or Problem

IT WAS REPORTED THAT DURING AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT SURGERY DEVICE WOULD NOT FILL MORE THAN 20CC DURING SURROGATE TESTING. TROUBLESHOOTING WAS PERFORMED TO CHECK IF DEACTIVATION BUTTON STUCK, HOWEVER IT WAS NOT. CYLINDERS DID NOT REMAIN INFLATED EVEN WHEN NOT PRESSING DEACTIVATION BUTTON. THE FAULTY IPP WAS NOT USED; INSTEAD, A NEW IPP TENACIO 2 WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT SURGERY DEVICE WOULD NOT FILL MORE THAN 20CC DURING SURROGATE TESTING. TROUBLESHOOTING WAS PERFORMED TO CHECK IF DEACTIVATION BUTTON STUCK, HOWEVER IT WAS NOT. CYLINDERS DID NOT REMAIN INFLATED EVEN WHEN NOT PRESSING DEACTIVATION BUTTON. THE FAULTY IPP WAS NOT USED; INSTEAD, A NEW IPP TENACIO 2 WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A THOROUGH ANALYSIS. THE CYLINDERS WERE VISUALLY INSPECTED, AND LEAK TESTED. BOTH CYLINDERS PASSED VISUAL INSPECTION. NO DAMAGE OR ABNORMALITIES WERE FOUND. BOTH CYLINDERS PASSED THE LEAKAGE TEST. THE REAL TIP EXTENDERS (RTES) WERE VISUALLY INSPECTED. NO DAMAGE OR ABNORMALITIES WERE FOUND. THE TENACIO PUMP WAS VISUALLY INSPECTED, LEAK AND FUNCTIONALLY TESTED. TENACIO PUMP PASSED VISUAL INSPECTION. NO DAMAGE OR ABNORMALITIES WERE FOUND. TENACIO PUMP PASSED THE LEAK AND FUNCTIONAL TESTING. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, A CONCLUSION CODE OF NO PROBLEM DETECTED WAS ASSIGNED TO THIS INVESTIGATION. THIS CONCLUSION WAS SELECTED BECAUSE THE REASON FOR DEVICE MECHANICAL ISSUE COULD NOT BE SUBSTANTIATED DURING FUNCTIONAL TESTING AND NO OTHER FAULT CONDITIONS WERE IDENTIFIED.