BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ENDOSCOPY 5MM X 32CM STRYKERPROBE SPATULA TIP AND SHEATH

    MDR report key: 10295180 · Received July 17, 2020

    Report

    Report Number
    MW5095591
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    July 5, 2020
    Report Date
    July 16, 2020
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE CAUTERY SHEATH BEGAN TO BURN AND MELT IN THE CAVITY. THE PHYSICIAN WAS UTILIZING THE DEVISE TO THE MANUFACTURER'S IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757080 STRYKER ENDOSCOPY 5MM X 32CM STRYKERPROBE SPATULA TIP AND SHEATH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY 250-070-441

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention