AMS 700 CX 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. FLUID LEAK AND INFLATION ISSUE ARE ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. 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 WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NON INFLATING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN IDENTIFIED FLUID LOSS FROM THE LEFT CYLINDER. THE ORIGINAL RESERVOIR WAS DRAINED AND RETAINED, AND ALL OTHER COMPONENTS WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.