BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HER OPTION PROBE

    MDR report key: 1970275 · Received January 14, 2011

    Report

    Report Number
    1216677-2011-00001
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 30, 2010
    Report Date
    January 3, 2011
    Manufacturer
    COOPERSURGICAL
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED TO COOPERSURGICAL FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    DOCTOR BELIEVES THAT THE PREVIOUSLY PLACED ESSURE TRANSMITTED THE COLD IN AN ABERRANT WAY - NO PERFORATION NOTED IN THE UTERUS, BUT DID HAVE ADNEXAL NECROSIS AND BOWEL INJURY. PT IS DOING OK NOW, HAD A TAH AND A SMALL BOWEL RESECTION OF A FOCAL 6CM AREA OF THERMALLY INJURED BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HER OPTION PROBE NONE GEH COOPERSURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention