AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO USE THE DEVICE DUE TO FLUID LOSS IN THE RIGHT CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A TORN RIGHT CYLINDER WAS IDENTIFIED. THE IPP WAS REPLACED, AND THE ORIGINAL RESERVOIR WAS DRAINED, CAPPED, AND LEFT IN THE RIGHT SPACE OF RETZIUS. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

B3: DATE OF EVENT. AN APPROXIMATE DATE WAS USED BECAUSE THE EXACT DATE OF THE EVENT WAS NOT PROVIDED. MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 903647012, 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. FLUID LEAKAGE 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 FLUID LOSS 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.