AMS 700 CXR MS PUMP

Description of Event or Problem

THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND A NON-CONFORMANCE WAS IDENTIFIED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100741332, MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML, UNIQUE IDENTIFIER (UDI) #: (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS THOROUGHLY INSPECTED AND ANALYZED. MICROSCOPIC ANALYSIS OF THE CYLINDERS NOTED WEAR IN A FOLD AT THE PROXIMAL END OF BOTH CYLINDERS; THE PUMP KINK RESISTANT TUBING (KRT) EXHIBITED WEAR FROM RUBBING AGAINST ITSELF. THE PUMP PASSED LEAKAGE TESTING BUT DID NOT PASS FUNCTIONAL ACTIVATION TESTING. A RISK REVIEW WAS COMPLETED USING THE AMS700 HAZARD ANALYSIS AND CONFIRMED THAT THE EVENT OF MECHANICAL MALFUNCTION (LEAKS, INCOMPLETE INFLATION/DEFLATION, KINKING) WAS DEFINED IN THE PRODUCT RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON THE AVAILABLE INFORMATION AND ANALYSIS FINDINGS, A MOST PROBABLE CONCLUSION OF CAUSE TRACED TO COMPONENT FAILURE WAS ASSIGNED TO THIS EVENT.