BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEX GENERATOR

    MDR report key: 6419250 · Received March 20, 2017

    Report

    Report Number
    1226420-2017-00109
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    October 26, 2016
    Report Date
    March 3, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K143175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BRIEF DESCRIPTION OF COMPLAINT: AN ABNORMAL SOUND AND A BURNT SMELL OCCURRED AT CUT 5. COMPLAINT DEVICE DETAILS: PRODUCT CODE (CFN): 40-405-1, SERIAL: (B)(4), TESTING PERFORMED: VISUAL INSPECTION: PACKAGING: GENERATOR WAS RETURNED IN AN APPROVED MAE BOX WITH PROPER FOAM PROTECTION. THE PACKAGING DID NOT APPEAR TO HAVE SUSTAINED DAMAGE DURING TRANSIT. EXTERNAL VISUAL: THERE WAS NO EVIDENCE OF EXTERNAL DEFECTS TO THE GENERATOR. INTERNAL VISUAL: THERE WAS EVIDENCE OF INTERNAL DEFECTS TO THE GENERATOR. DEFECT(S) FOUND: AFTER OPENING THE GENERATOR SERVICE FOUND A COMPONENT (L21) ON THE RF PCB WAS SUBJECTED TO AN OVER CURRENT CONDITION. UPON RETURN TO (B)(4) IT WAS CONFIRMED THAT L21 WAS DEFECTIVE DUE TO AN OVERCURRENT CONDITION. IMPACT ON FUNCTIONALITY: DUE TO ELECTRICAL SAFETY CONCERNS, NO FUNCTIONAL TESTING WAS CARRIED OUT AT MAE PRIOR TO UNIT BEING RETURNED TO (B)(4). RESOLUTION OF DEFECT(S) (FIX): ONCE RETURNED TO (B)(4)L21 WAS REPLACED. ONCE REPLACED UNIT FUNCTIONED PROPERLY. FUNCTIONAL INSPECTION OF GENERATOR RELATED TO REPORTED ISSUE(S): TEST(S) PERFORMED IN ACCORDANCE WITH REPORTED ISSUE: DUE TO ELECTRICAL SAFETY CONCERNS, NO FUNCTIONAL TESTING WAS CARRIED OUT AT MAE PRIOR TO UNIT BEING RETURNED TO (B)(4). FUNCTIONAL UNIT TEST STATION (FUT) TEST(S) ((B)(4)) ARE MEASUREMENTS WITHIN SPECIFICATION?: NO EQUIPMENT USED FOR TESTING: (B)(4) FUT STATION RESULTS OF EACH TEST PERFORMED: UNIT FAILED FUT FOR POWER ISSUE. L21 STARTED SMOKING AS SOON AS UNIT ACTIVATED POWER. UNIT WAS MANUALLY SHUT DOWN IMMEDIATELY TO AVOID FURTHER DAMAGE. DUE TO ELECTRICAL SAFETY ISSUES, NO FUNCTIONAL TESTING WAS CONDUCTED PRE-REPAIR. DESCRIBE DEFECT FOUND AND IMPACT TO FUNCTIONALITY: L21 WAS FOUND DEFECTIVE WHICH RESULTS IN NO POWER OUT. DESCRIBE RESOLUTION OF DEFECT (FIX): (B)(4)REPLACED L21. ONCE REPLACED UNIT PASSED ALL FUNCTIONAL AND OPERATIONAL TESTING. POST REPAIR POWER OUTPUT RESULTS ARE BELOW. WERE THERE ADDITIONAL FAILURES FOUND? NO SLHR REVIEW: THIS GENERATOR HAS NOT BEEN IN FOR SERVICE PRIOR TO THIS COMPLAINT. INVESTIGATION CONCLUSION: THE REPORTED ISSUE WAS CONFIRMED. REFERENCE DOCUMENTS: COMPLAINT ANALYSIS-GENERATORS-WORK INSTRUCTIONS 42-10-1119 REV C AEX SERVICE PROCESS INSTRUCTIONS 61-90-0703 REV G. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SERVICE INITIATED COMPLAINT: THIS GENERATOR WAS RETURNED WITH NO ISSUES REPORTED. SERVICE REPORTED AS SOON AS THE GENERATOR ACTIVATED POWER THE L21 STARTED SMOKING. THE GENERATOR WAS MANUALLY SHUT DOWN IMMEDIATELY. THERE WAS NO INJURY REPORTED. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE PATIENT INFORMATION IS NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199875 AEX GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) 40-405-1

    Patients

    Seq Age Sex Outcome Treatment
    1