BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANCE HANDPIECE

    MDR report key: 6121703 · Received November 22, 2016

    Report

    Report Number
    3006443171-2016-00005
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 21, 2016
    Manufacturer
    HALT MEDICAL, INC.
    Product Code
    HFG
    PMA / PMN Number
    K121858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS SHOWED NO EVIDENCE OF A MANUFACTURING PROBLEM WITH THE DEVICE. EVIDENCE SHOWED THAT THE HANDPIECE WAS ADVANCED WHILE THE NEEDLES WERE DEPLOYED CAUSING A SHARP BEND ON THE CENTER NEEDLE. RETRACTING THE ARRAY MAY HAVE CAUSED THE CENTER NEEDLE TO BREAK. IFU PL-01-0014, PL-01-0016 AND PL-01-0033 PROVIDE PRECAUTIONS WITH REGARDS TO POSITIONING AND ADVANCING THE DEVICE WHILE NEEDLES ARE DEPLOYED. TRAINING MATERIAL (PE-00-0102 AND PE-00-0103) PROVIDES FIELD STAFF AND PROCTORS WITH PRECAUTIONS WITH REGARDS TO POSITIONING/ADVANCING THE DEVICE WHILE NEEDLES ARE DEPLOYED.

    Description of Event or Problem · 1

    AN ELECTRODE FROM THE GUIDANCE HANDPIECE (MODEL NUMBER 5300, LOT NUMBER 160810) BROKE DURING THE PROCEDURE AT (B)(6) HOSPITAL WITH DR. (B)(6) THE UTERUS WAS ESTIMATED TO BE 24 WEEKS IN SIZE. THE FIBROID BEING TREATED WAS ESTIMATED TO BE BETWEEN 10CM TO 15CM IN SIZE. DURING THE HANDPIECE POSITIONING, HALT FIELD REP. OBSERVED PUSHING OF THE HANDPIECE WHILE NEEDLES WERE DEPLOYED AND CAUTIONED THE DOCTOR TO NOT ADVANCE WHILE NEEDLES ARE DEPLOYED. THE FIELD REP ASKED THE DOCTOR AFTER THE 6TH OR 7TH ABLATION TO CHECK THE NEEDLES, AND NOTICED NEEDLE #7 WAS SHORTER THAN THE OTHERS WHEN FULLY DEPLOYED DURING A TEST DEPLOYMENT. ON NOV. 17, 2016, DR. (B)(6) WAS NOTIFIED THAT THE MISSING NEEDLE FRAGMENT (1.2CM IN LENGTH) WAS NOT LOCATED WITHIN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770442 GUIDANCE HANDPIECE GUIDANCE HANDPIECE HFG HALT MEDICAL, INC. 5300 160810

    Patients

    Seq Age Sex Outcome Treatment
    1