AMS 700 LGX MS Pump

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. 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 A PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED, AND THE RIGHT CYLINDER WAS FOUND FRACTURED. THE PUMP AND BOTH CYLINDERS WERE REPLACED WITH A LENGTH SIZE MORE SUITABLE FOR THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.