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. INCOMPLETE INFLATION, FLUID LOSS AND MECHANICAL ISSUES ARE ACKNOWLEDGED WITHIN THE DIRECTIONS FOR USE (DFU) AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. A RISK REVIEW WAS COMPLETED; INFLATION ISSUE, FLUID LOSS AND NON-FUNCTIONING DEVICES ARE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. 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 THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT INFLATE AND EXHIBITED FLUID LOSS. UPON REMOVAL, SEVERE STRUCTURAL DAMAGE TO THE TUBING WAS OBSERVED, INCLUDING EXPOSURE OF SUTURE WIRE AND TUBING THAT WAS FUSED TOGETHER. NO PATIENT COMPLICATIONS WERE REPORTED.