BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACESSA HANDPIECE

    MDR report key: 5728101 · Received June 15, 2016

    Report

    Report Number
    3006443171-2016-00002
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Date of Event
    May 11, 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

    SEE MFR. REPORT #3006443171-2016-00001. THE SAME DOCTOR CONTINUED THE CASE WITH A 2ND HANDPIECE (MODEL NUMBER 2000, LOT NUMBER T150101). THE 10CM FIBROID WAS TREATED NUMEROUS TIMES. DURING ONE OF THE ABLATIONS, IT WAS NOTED IN THE MIDST OF THE TREATMENT THAT A TEMPERATURE READING WAS MISSING FROM NEEDLE #7. THE HANDPIECE WAS RETRACTED AFTER COMPLETION OF THAT TREATMENT AND INSPECTED BOTH LAPAROSCOPICALLY AND OUTSIDE OF THE PATIENT FOR POTENTIAL DAMAGE TO NEEDLE #7. AT THAT TIME, NEEDLE #7 WAS NOT EXTENDING ALONG WITH THE OTHER 6 NEEDLES, INDICATING A POSSIBLE BREAKAGE IN THE NEEDLE SIMILAR TO THE FIRST HANDPIECE. A THIRD HANDPIECE WAS PULLED FROM CUSTOMER STOCK (MODEL NUMBER 2000, LOT NUMBER T150101) TO COMPLETE THE PROCEDURE ON THE SECOND FIBROID. NO ISSUES WERE ENCOUNTERED WITH THE THIRD HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381019 ACESSA HANDPIECE ACESSA HANDPIECE HFG HALT MEDICAL, INC. 2000 T150101

    Patients

    Seq Age Sex Outcome Treatment
    1