BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4932407 · Received July 22, 2015

    Report

    Report Number
    2027111-2015-00474
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    July 2, 2015
    Report Date
    September 1, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K141288
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OBTAIN LOT# UPON DEVICE KEY RETURNED - 1243280. INVESTIGATION SUMMARY: THE DEVICE KEY OF THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING REVIEWED THE DEVICE LOGS AND NOTED 4 'REACTIVATE SWITCH RELEASED' MESSAGES OUT OF 130 ACTIVATIONS. IN THE ABSENCE OF THE COMPLETE DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT CONFIRMED THAT THE PRODUCT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. THE ROOT CAUSE OF THE INCIDENT REMAINS UNKNOWN AS THE COMPLETE DEVICE WAS NOT RETURNED. ACCORDING TO THE DEVICE LOGS, THE DEVICE WAS ABLE TO COMPLETE THE MAJORITY OF THE SEAL CYCLES WITH VERY FEW INTERRUPTIONS. A 'REACTIVATE' ALARM WILL OCCUR IF THE SEAL CYCLE IS INTERRUPTED BEFORE THE CYCLE IS COMPLETE OR IF THE MAXIMUM SEAL CYCLE TIME IS REACHED. THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS THE USER TO REACTIVATE THE SEAL CYCLE WITHOUT REPOSITIONING THE DEVICE. REGARDING THE ERGONOMICS OF THE DEVICE, APPLIED MEDICAL WISHES TO EXTEND ASSURANCES THAT THESE CONCERNS WERE HEARD AND WE VALUE THIS FEEDBACK. THESE SUGGESTIONS WILL BE KEPT IN MIND FOR FUTURE PROJECT IMPROVEMENTS TO HELP DRIVE INNOVATION. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Additional Manufacturer Narrative · 1

    RA HAS RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP HEMICOLETOMY RIGHT- "DURING THE PROCEDURES SEVERAL TISSUE BUNDLES AND VESSELS STARTED BLEEDING AFTER A FEW SECONDS AFTER SEALING. SURGEON WAS VERY UNSATISFIED ABOUT HEMOSTASIS AND ALSO ABOUT ERGONOMICS, HANDLE, HEAVYNESS, KNIFEPERFORMANCE." PATIENT STATUS- " NO COMPLICATIONS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475991 EB010, VOYANT 5MM FUSION, 37CM 6/BX GEI GEI APPLIED MEDICAL EB010 1243280

    Patients

    Seq Age Sex Outcome Treatment
    1 Other