AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT DURING IMPLANTATION OF THIS INFLATABLE PENILE PROSTHESIS (IPP), INTRAOPERATIVE MODELING WAS PERFORMED FOLLOWING PLACEMENT OF THE IMPLANT. THE TUBING CONNECTED TO THE PUMP AND CYLINDERS WAS CLAMPED DURING MODELING AND SUBSEQUENTLY UNCLAMPED PRIOR TO DEVICE TESTING WITH CONNECTION TO A SURROGATE RESERVOIR. DURING FUNCTIONAL TESTING, NO TACTILE FEEDBACK WAS OBSERVED UPON PUMP ACTUATION, INCLUDING ABSENCE OF BUZZING OR VIBRATION, AND THE PUMP DID NOT FUNCTION AS INTENDED, AS FLUID DID NOT TRANSFER INTO OR OUT OF THE PUMP, RESULTING IN NO INFLATION OR DEFLATION. TROUBLESHOOTING ATTEMPTS, INCLUDING REPEATED INFLATION AND DEFLATION ATTEMPTS AND ACTUATION OF THE PUMP SIDEBARS, WERE UNSUCCESSFUL. THE SURROGATE RESERVOIR WAS CONFIRMED TO BE PROPERLY FILLED AND CONNECTED PRIOR TO TESTING. NO AIR WAS OBSERVED IN THE DEVICE. NO HOLE OR DAMAGE WAS IDENTIFIED IN THE PUMP; HOWEVER, FOLLOWING COMPRESSION, THE PUMP BULB REMAINED DEFLATED WITH AN INDENTATION AND SLOWLY REFILLED, WITH FLUID ATTEMPTING TRANSFER TO THE CYLINDERS. THE DEVICE WAS REMOVED AND REPLACED WITH AN ALTERNATE DEVICE DURING THE SAME PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

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. DEFLATION ISSUE, INFLATION ISSUE AND MECHANICAL 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.