BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACESSA GUIDANCE HAND PIECE

    MDR report key: 7134061 · Received December 20, 2017

    Report

    Report Number
    3006443171-2017-00002
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 1, 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 RISK 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 IS FOR USERS TO EVALUATE PACKAGING PRIOR TO USE. THE IFU STATES DO NOT USE IF PRODUCT OR PACKAGING IS DAMAGED (PL-01-0033-F). COMMUNICATIONS WITH DR. (B)(6) CONTINUE TO EVALUATE THE PATIENTS HEALTH AND DR. WEST HAS STATED THAT CURRENTLY PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    PATIENT RE-ADMITTED TO HOSPITAL 10 DAYS FOLLOWING NOVASURE/ACESSA PROCEDURE WITH TENDER UTERUS AND LOW GRADE FEVER. PATIENT HAS BEEN ON IV ANTIBIOTICS AND RECENTLY A PIC LINE WAS ADMINISTERED. FEVER AND WBC COUNT NOW DOWN BUT PATIENT STILL EXPERIENCING BREAK THROUGH FEVERS IN LOW 100'S FROM TIME TO TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914425 ACESSA GUIDANCE HAND PIECE ACESSA HFG ACESSA HEALTH INC. 5300 UNKNOWN - NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NOVASURE