AMS 700 LGX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) STOPPED INFLATING. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1000520616, MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML, UNIQUE IDENTIFIER (UDI) #: (B)(4). 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 IS ACKNOWLEDGED WITHIN THE DIRECTIONS FOR USE (DFU) AND IS NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. A RISK REVIEW WAS COMPLETED, AND INFLATION ISSUE IS 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.