BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACESSA HANDPIECE

    MDR report key: 4813415 · Received June 2, 2015

    Report

    Report Number
    3006443171-2015-00001
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    March 1, 2015
    Report Date
    May 1, 2015
    Manufacturer
    HALT MEDICAL, INC.
    Product Code
    HFG
    PMA / PMN Number
    K121858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH DEVICE ITSELF CANNOT BE EVALUATED, HALT LOOKED INTO RISK ASSESSMENTS AND FOUND THAT IF DEVICE WAS USED IN SUCH A WAY THAT IF THE TROCAR/NEEDLES WERE DEPLOYED THAT IT TOUCHED THE BLADDER AND MAY HAVE ACCIDENTALLY ABLATED THE BLADDER TISSUE. THIS PUNCTURE OF OTHER ORGANS DURING A LAPAROSCOPIC PROCEDURE IS NOT AN UNKNOWN ADVERSE EVENT. IN THE CASE OF THE ACESSA SYSTEM, THIS ISSUE HAS HAPPENED 1 OUT OF ABOUT 1000 CASES WITH EACH CASE HAVING AN AVERAGE OF ABOUT 4-6 FIBROIDS BEING ABLATED. SO IN REALITY 4000 TO 6000 ABLATIONS PERFORMED WITH ONLY 1 CASE OF "THERMAL INJURY". THE RATE OF FREQUENCY IS VERY LOW. IN ADDITION, WE ALSO DO NOT KNOW IF THE PATIENT HAD OTHER PROCEDURES BESIDES THE ACESSA. WE ALSO DID NOT HAVE ANY INFORMATION OR DETAILS REGARDING THE DIAGNOSIS AND UROLOGIC SURGERY THE PATIENT HAS GONE THROUGH. WHICH MADE EVALUATION DIFFICULT. NOT RECEIVED; KNOWN LAPAROSCOPIC RISK.

    Description of Event or Problem · 1

    SEVERAL WEEKS AFTER UTERINE FIBROID TREATMENT AT (B)(6) ON (B)(6) 2015, DR. WAS APPROACHED BY THE PATIENT REGARDING HER ISSUES AROUND (B)(6) 2015. DURING HER TREATMENT THERE WERE NO KNOWN COMPLICATIONS HOWEVER SEVERAL WEEKS LATER SHE COMPLAINED OF BLADDER SYMPTOMS AND A BLADDER INJURY WAS APPARENTLY DIAGNOSED BY ANOTHER DOCTOR. HE ASKED TO HAVE A FOLLOW-UP WITH THE PATIENT BUT SHE DECIDED TO GET TREATED AT (B)(6) INSTEAD. THERE SHE HAD A UROLOGIC SURGERY TO TREAT THE BLADDER THERMAL INJURY. DR. (B)(6) THEN REPORTED THIS ISSUE TO HALT ON (B)(6) 2015. THERE WERE NO DETAILED PATIENT INFORMATION RECEIVED BY HALT OR WHETHER OR NOT THE PATIENT HAS HAD OTHER PROCEDURES BEFORE ACESSA OR AFTER. NOTE THAT DR. (B)(6) HAS PERFORMED ABOUT 95 PROCEDURES AS OF EARLY (B)(6) OF THIS YEAR WITH NO COMPLICATIONS SUCH AS THIS. THE ACESSA SYSTEM HAS ALSO BEEN USED IN ABOUT 1000 PROCEDURES WITH THIS AS THE FIRST KNOWN THERMAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354561 ACESSA HANDPIECE ACESSA HANDPIECE HFG HALT MEDICAL, INC. 2000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention