BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULATION STEALTH ON J HOOK

    MDR report key: 5366136 · Received January 11, 2016

    Report

    Report Number
    MW5059300
    Event Type
    Injury
    Date Received
    January 11, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 11, 2016
    Manufacturer
    STRYKER
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE J HOOK ON THE UTERUS WHEN THE INSULATION STEALTH AROUND THE INSTRUMENT INADVERTENTLY TOUCHED THE FALLOPIAN TUBE CAUSING A SLIGHT BURN. THE MALFUNCTIONED TUBE WAS FOUND AT THE END OF THE PROCEDURE TO BE MELTED AT THE TIP. NO HARM TO THE PATIENT. THE MAIN CONCERN IS POSSIBLE SCAR TISSUE LATER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18335 INSULATION STEALTH ON J HOOK J HOOK GEI STRYKER 250-070-460 072115-10

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR