BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACESSA GUIDANCE HANDPIECE

    MDR report key: 7131218 · Received December 19, 2017

    Report

    Report Number
    3006443171-2017-00001
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 14, 2017
    Manufacturer
    ACESSA HEALTH 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

    DEVICE NOT AVAILABLE FOR INVESTIGATION OR TESTING, THEREFORE ROOT CAUSE ANALYSIS OF DEVICE WAS NOT POSSIBLE. HAZARD ANALYSIS (FA-01-0003-Q. I.D. 94) DESCRIBES A POSSIBLE HAZARD WITH PACKAGING BEING COMPROMISED PRIOR TO USE RESULTING IN CONTAMINATION OF DEVICE AND PATIENT FEVER. THIS IS HIGHLY UNLIKELY AS STANDARD OF CARE REQUIRES USERS TO EVALUATE PACKAGING PRIOR TO USE. THE IFU STATES DO NOT USE IF PRODUCT OR PACKAGING IS DAMAGED (PL-01-0033-F). EMAIL UPDATE WAS RECEIVED ON (B)(6) 2017 FROM (B)(6) THAT STATED: "CURRENTLY THE PATIENT IS DOING WELL AND HAS HAD NO SEQUELAE AFTER HER RECOVERY."

    Description of Event or Problem · 1

    PATIENT RE-ADMITTED TO HOSPITAL 3 DAYS FOLLOWING NOVASURE/ACESSA PROCEDURE WITH HEAVY BLEEDING AND LOW GRADE FEVER. WHILE IN THE HOSPITAL, BLEEDING WAS CONTROLLED AND PATIENT WAS FOUND TO HAVE UTI. PATIENT WAS TREATED WITH ANTI-BIOTIC AND DISCHARGED. PATIENT RETURNED 2 DAYS LATER WITH LOW GRADE FEVER AGAIN. WHITE BLOOD CELL COUNT WAS ELEVATED. CT SCAN SHOWED NOTHING OF CONSEQUENCE. ON (B)(6) 2017 PATIENT DISCHARGED AGAIN. PATIENT WOKE UP ON (B)(6) 2017 WITH LOW GRADE FEVER AND IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908590 ACESSA GUIDANCE HANDPIECE ACESSA HFG ACESSA HEALTH INC. 5300 17051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other