BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACESSA GUIDANCE HANDPIECE

    MDR report key: 5828247 · Received July 27, 2016

    Report

    Report Number
    3006443171-2016-00003
    Event Type
    Injury
    Date Received
    July 27, 2016
    Date of Event
    June 21, 2016
    Report Date
    July 11, 2016
    Manufacturer
    HALT MEDICAL, INC.
    Product Code
    HFG
    PMA / PMN Number
    K121858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION (LOT# 160101). (B)(6) REVIEWED THE ACESSA SYSTEM HAZARD ANALYSIS (B)(4). REVIEW DETERMINED THAT THIS TYPE OF RISK MAY OCCUR (HAZARD ANALYSIS I.D. (B)(4)) WHICH WOULD RESULT IN PATIENT BURN WHEN RF IS APPLIED AND THE DEVICE IS NOT POSITIONED CORRECTLY, IN THIS CASE THE ACCIDENTAL ABLATION OF BLADDER TISSUE. THIS "THERMAL INJURY" ISSUE IS THE 2ND OCCURRENCE IN APPROXIMATELY (B)(4) CASES. EACH CASE AVERAGES 4-6 FIBROID TREATMENTS, THEREFORE, THERE ARE APPROXIMATELY (B)(4) ABLATIONS PERFORMED WITH ONLY (B)(4) KNOWN CASES OF "THERMAL INJURY". THE RATE OF FREQUENCY IS CONSIDERED (B)(4). IN ADDITION, WE ALSO DO NOT KNOW IF THE MYOMECTOMY PROCEDURE MAY HAVE CONTRIBUTED TO THIS "THERMAL INJURY" ISSUE. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2016 DR. (B)(6) TREATED A PATIENT FOR UTERINE FIBROIDS WITH THE ACESSA PROCEDURE AT (B)(6) CENTER, (B)(6). THE PATIENT COMPLAINED OF BLADDER SYMPTOMS AND A BLADDER INJURY WAS DIAGNOSED BY AN UROLOGIST VIA A CYSTOSCOPY ON THE INNER WALL OF THE BLADDER. DR. (B)(6) CONTACTED THE SALES DIRECTOR OF (B)(6) MEDICAL ON (B)(6) 2016 AND NOTIFIED HIM THAT HIS PATIENT EXPERIENCE A THERMAL BLADDER INJURY. THE PATIENT WAS TREATED FOR UTI AND REPORTED TO BE DOING WELL. IT WAS ALSO NOTED AFTER THE ACESSA PROCEDURE, A DECISION WAS MADE TO PERFORM AN ABDOMINAL MYOMECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477948 ACESSA GUIDANCE HANDPIECE GUIDANCE HANDPIECE HFG HALT MEDICAL, INC. 5300 160101

    Patients

    Seq Age Sex Outcome Treatment
    1