BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACESSA HANDPIECE

    MDR report key: 3750341 · Received January 31, 2014

    Report

    Report Number
    3006443171-2014-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 23, 2014
    Manufacturer
    HALT MEDICAL, INC.
    Product Code
    HFG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO REMEDIAL OR CORRECTIVE ACTION WAS INITIATED BECAUSE THE TRAINING PROCEDURE, PRESENTATION, MANUAL, ETC. DID DESCRIBE SUCH EVENTS AND PREVENTION OF SUCH EVENTS. SINCE NO OTHER PHYSICIANS HAVE HAD THIS EXPERIENCE AMONG THOSE TRAINED TO USE THE ACESSA SYSTEM, THIS WAS CONSIDERED AN ISOLATED CASE. NOTE ALSO THAT THIS CASE WAS ONLY THE SECOND CASE OF DR (B)(6). THEREFORE, HE WAS STILL BEING PROCTORED BY DR (B)(6), THE REPORTING PHYSICIAN AND TRAINER. DR (B)(6) HAD FELT THAT THE MISCOMMUNICATION DURING SURGERY WAS THE REASON FOR THE EVENT AND ONCE THAT WAS CLEARED UP, WHEN ANOTHER ACESSA DEVICE WAS USED, THE RESULT WAS SUCCESSFUL WITH NO ISSUES. (B)(6) IN AN E-MAIL TO HALT TO ONE OF THE SALES REPS LATER STATED THAT THE PT WAS DOING VERY WELL AND WAS VERY THANKFUL TO BE TREATED BY THE PROCEDURE. BOTH THE DOCTOR AND THE PT PERCEIVED THE CASE TO BE A SUCCESS EVENT WITH THIS ISSUE.

    Description of Event or Problem · 1

    ONE OF THE 7 ELECTRODE NEEDLE FROM THE ACESSA HANDPIECE (MODEL NUMBER 2000, LOT NUMBER T130901) BROKE DURING USE IN A SURGICAL TRAINING PROCEDURE AT (B)(6) HOSPITAL WITH DR (B)(6). DR (B)(6), THE TRAINER, STATED THAT THE EVENT OCCURED BECAUSE OF MISCOMMUNICATION BETWEEN HIM AND DR. (B)(6) ON HANDLING THE DEVICE. DR (B)(6) WAS HAVING ISSUES WITH STABILIZATION OF THE UTERUS AND VIGOROUSLY TRIED TO WITHDRAW THE DEVICE FROM THE FIBROID, PUSHING IT IN AND OUT SEVERAL TIMES RESULTING IN SEVERE BENDING OF A NEEDLE AND BREAKING IT. THE BROKEN PART OF THE NEEDLE WAS EASILY GRASPED AND REMOVED FROM THE FIBROID AND THIS EVENT DID NOT RESULT IN ANY PT INJURY OR CAUSE BLEEDING. THE PROCEDURE CONTINUED WITH A NEW DEVICE SUCCESSFULLY ONCE DR (B)(6) WAS MADE AWARE OF HOW TO HANDLE THE DEVICE APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67017 ACESSA HANDPIECE ACESSA HANDPIECE HFG HALT MEDICAL, INC. 2000 T130901

    Patients

    Seq Age Sex Outcome Treatment
    1