BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE CIRCUMFERENTIAL FIRE, FLEXIBLE

    MDR report key: 9928243 · Received April 6, 2020

    Report

    Report Number
    9928243
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    November 26, 2019
    Report Date
    March 4, 2020
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN USED FLEXIBLE ARGON PROBE DURING COLONOSCOPY. WHEN PHYSICIAN PULLED WIRE FROM BIOPSY CHANNEL, WHITE BALL IN END OF WIRE WAS GONE AND 2 EXPOSED WIRES WERE SHOWING. SURGICAL TEAM WAS ABLE TO OBTAIN BALL FROM INSIDE SCOPE. SCOPE WENT THROUGH AIR AND CLEANING AS USUAL WITH NO ALARMS/ ALERTS. MANUFACTURER RESPONSE FOR ARGON CABLE, CIRCUMFERENTIAL FIRE, FLEXIBLE (PER SITE REPORTER): EQUIPMENT FAILURE REPORTED TO [email protected]. TECHNICAL SERVICES SUPERVISOR PROCESSED COMPLAINT. EQUIPMENT RETURNED TO ERBE-USA INC. (B)(4) VIA (B)(6). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393990 ERBE CIRCUMFERENTIAL FIRE, FLEXIBLE ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI ERBE ELEKTROMEDIZIN GMBH 20132-218 134091

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA