BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB010, VOYANT 5MM FUSION, 37CM 6/BX

    MDR report key: 4940833 · Received July 25, 2015

    Report

    Report Number
    2027111-2015-00492
    Event Type
    Malfunction
    Date Received
    July 25, 2015
    Date of Event
    April 21, 2015
    Report Date
    July 24, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K141288
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. ENGINEERING PERFORMED VISUAL AND FUNCTIONAL TESTING ON THE DEVICE. UPON INSPECTION, THE DEVICE MET ALL MECHANICAL SPECIFICATIONS BUT DID NOT MEET THE ELECTRICAL CONTINUITY REQUIREMENTS. DURING TESTING, ENGINEERING FOUND THAT THE DISTAL CONDUCTIVE STOP WAS SHORTING TO THE LOWER JAW. THIS WOULD RESULT IN "CHECK DEVICE" ALARMS DESCRIBED IN THE INCIDENT EXPERIENCE. ENGINEERING WAS ABLE TO REPLICATE THE ALARMS WHEN THE DEVICE WAS ACTIVATED AND ANALYSIS OF THE DEVICE KEY ACTIVATION LOGS ALSO CONFIRMED THE INCIDENT EXPERIENCE. THE ROOT CAUSE OF THE INCIDENT WAS DUE TO AN ELECTRICAL SHORT BETWEEN THE DISTAL CONDUCTIVE STOP AND THE LOWER JAW. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. AS A RESULT OF THIS FEEDBACK, ADDITIONAL INSPECTION STEPS AND PROCESS ENHANCEMENTS HAVE BEEN ADDED TO THE MANUFACTURING PROCESS TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO REOCCUR. THIS DOCUMENT REPRESENTS OUR INITIAL/FINAL REPORT.

    Description of Event or Problem · 1

    T.L.H.( HYSTERECTOMIE) :" STARTED WELL, SEEMS TO BLEED A BIT MORE COMPARED TO OTHER DEVICES. THEN, WE'VE GOT 10 NO PROBLEM DURING THE TLH SUDDENLY, WE'VE GOT SEVERAL ALARMS, THE KNOW OF "CLEAN INSTRU; LITTLE BIT OF TISSUE...." THEN IT WORK FOR ANOTHER 10 SEALS VERY GOOD AND AGAIN SOME ALARM." PATIENT STATUS:" NO PROBLEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484908 EB010, VOYANT 5MM FUSION, 37CM 6/BX GEI GEI APPLIED MEDICAL EB010 1240553

    Patients

    Seq Age Sex Outcome Treatment
    1 Other