BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 489102 · Received October 10, 2003

    Report

    Report Number
    489102
    Event Type
    Malfunction
    Date Received
    October 10, 2003
    Date of Event
    December 1, 2002
    Report Date
    January 1, 2003
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FFZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ESU CAUTERY CORD CAUGHT FIRE DURING A PROCEDURE. THE FIRE WAS DESCRIBED AS SPARKS AND SMOKE ONLY, NO ACTUAL FIRE. THE CORD AND ESU WERE REMOVED FROM THE ROOM. NO INJURY WAS CAUSED TO THE PATIENT. THE REPORTING NURSE SAID THAT THE USERS [SURGICAL TECHS] HAD BENT THE CORD AND TAPED IT TO THE SCISSORS TO KEEP THE CONNECTOR FROM FALLING OUT. DEVICE USAGE PROBLEM: DEVICE FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ELECTROSURGICAL UNIT ACTIVE ELECTRODE UNIPOLAR CORD FFZ KARL STORZ ENDOSCOPY-AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other 2. ESU SCISSOR.| 1. VALLEYLAB MODEL FORCE FX ELECTROSURGICAL UNIT.