BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACESSA HANDPIECE

    MDR report key: 5728100 · Received June 15, 2016

    Report

    Report Number
    3006443171-2016-00001
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Date of Event
    November 5, 2016
    Report Date
    June 6, 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

    THE CORRECTIVE ACTION SHALL FOCUS ON REINFORCEMENT OF CURRENT LANGUAGE IN THE USER TRAINING MATERIAL/IFU WITH REGARDS TO ADVANCING THE DEVICE WHILE ARRAY IS DEPLOYED. NOTE THAT THIS WAS A TRAINING CASE; THEREFORE THE DOCTOR WAS STILL BEING PROCTORED.

    Description of Event or Problem · 1

    ONE OF THE 7 ELECTRODE ARRAY NEEDLES FROM THE ACESSA HANDPIECE (MODEL NUMBER 2000, LOT NUMBER T150101). BROKE DURING A SURGICAL PROCEDURE AT (B)(6) WITH DR. (B)(6) AND PHYSICIAN PROCTOR, DR. (B)(6) FROM (B)(6). THE EVENT OCCURRED DURING HANDPIECE PLACEMENT INTO A 10CM FIBROID. IT APPEARS THE HANDPIECE WAS PLACED INTO THE FIBROID AND THE ARRAY DEPLOYED TO 3CM. IT WAS NOTED THAT THE ARRAY WAS FURTHER DEPLOYED AN ADDITIONAL 2CM. THE ARRAY WAS RETRACTED DUE TO INABILITY TO OPTIMALLY DEPLOY BEYOND THIS POINT. THE DOCTOR WITHDREW THE HAND PIECE FROM PATIENT TO INSPECT. AT THAT TIME, THE HAND PIECE WAS INSPECTED AND THE ABILITY TO DEPLOY WAS ASSESSED. THE ARRAY COULD NOT BE DEPLOYED. A SECOND HANDPIECE WAS PULLED FROM CUSTOMER STOCK TO PROCEED WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379524 ACESSA HANDPIECE ACESSA HANDPIECE HFG HALT MEDICAL, INC. 2000 T150101

    Patients

    Seq Age Sex Outcome Treatment
    1