AMS 700 LGX? TENACIO? PUMP

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) COMPLAINING THAT THE PUMP WAS NOT WORKING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE TENACIO PUMP WAS REPLACED WITH A MS PUMP. AFTER THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WORKS WELL OUTSIDE THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404155. SERIAL NUMBER: N/A . BATCH/LOT NUMBER: 1100560048. MODEL/CATALOG DESCRIPTION: RESERVOIR 65 ML PC/IZ. 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. THE REPORTED MECHANICAL ISSUE IS 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, AND NON-FUNCTIONING DEVICE ISSUES 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.