BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC MONOPOLAR SPATULA TIP AND SHEATH

    MDR report key: 2756834 · Received September 17, 2012

    Report

    Report Number
    2756834
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 17, 2012
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING A LAPAROSCOPIC CHOLECYSTECTOMY. SURGEON WAS USING A STRYKER 250-070-446 LAPAROSCOPIC MONOPOLAR SPATULA TIP. THE SHEATH WAS GETTING SO HOT THAT IT WAS MELTING. THE SURGEON HAD TO USE THREE DIFFERENT SHEATHS DURING THE PROCEDURE. OTHERWISE PROCEDURE WAS COMPLETED WITHOUT UNTOWARD EFFECTS. PATIENT TO RECOVER IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC MONOPOLAR SPATULA TIP AND SHEATH ELECTROSURGICAL, CUTTING, COAGULATION GEI STRYKER ENDOSCOPY * 12G0403

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR