AMS 700? CX TENACIO? PUMP

Additional Manufacturer Narrative

DETAILED PRODUCT INFORMATION FOR THE AMS 700 CX TENACIO PUMP WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. 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 THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PHYSICIAN TOOK THE PUMP AND RESERVOIR OUT OF TO TROUBLESHOOT AND WORKED GREAT, HOWEVER, WHEN HE PUT BACK THE COMPONENTS THE DEVICE WON'T INFLATE BEHIND 80%. THEREFORE, THE IPP WAS FULLY REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.