AMS 700 LGX? TENACIO? PUMP

Additional Manufacturer Narrative

UPON RECEIPT AT THE QUALITY ASSURANCE LABORATORY, THE RETURNED COMPONENTS UNDERWENT A COMPREHENSIVE EVALUATION. BOTH CYLINDERS PASSED VISUAL INSPECTION WITH NO DAMAGE OR ABNORMALITIES OBSERVED AND SUCCESSFULLY PASSED LEAKAGE TESTING. THE TENACIO PUMP PASSED VISUAL INSPECTION WITH NO DAMAGE OR ABNORMALITIES IDENTIFIED AND SUCCESSFULLY PASSED LEAK AND FUNCTIONAL TESTING. DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. A RISK REVIEW WAS COMPLETED 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 BENEFITS FOR THE PRODUCT. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS RESULTS, THE TENACIO PUMP WAS FOUND TO BE THE OVER INSERTION OF THE KRT INTO THE PUMP BLOCK DURING MANUFACTURING. THE ALLEGATION OF A PUMP MECHANICAL ISSUE WAS MOST LIKELY DUE TO THE OVER INSERTED KINK RESISTANT TUBING (KRT). A CONCLUSION CODE OF QUALITY CONTROL DEFICIENCY WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT PROCEDURE, THE MEDICAL STAFF NOTED THAT THE VALVE PUMP WAS OPENING WHILE TRYING TO INFLATE THE DEVICE, RESULTING IN SPONTANEOUS DEFLATION; THEREFORE, A DIFFERENT PUMP WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.