BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TONSIL SNARE

    MDR report key: 5839399 · Received August 2, 2016

    Report

    Report Number
    5839399
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 27, 2016
    Manufacturer
    AESCULAP
    Product Code
    KBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NEW SNARE GUN WAS USED IN THE BILATERAL TONSILLECTOMY PROCEDURE THAT WAS SCHEDULED. PER SURGEON, THE SNARE GUN MISFIRED AND THE SNARE WIRE USED "SHEARD" SURROUNDING TISSUE OF THE TONSILS, CAUSING ADDITIONAL BLEEDING. SURGEON USED ADDITIONAL CAUTERY TO CAUTERIZE INJURED VESSELS. THIS PROLONGED THE PROCEDURE TIME, THUS PROLONGING ANESTHESIA TIME. AFTER THE EVENT IN THE OPERATING ROOM: AESCULAP SENT THE GUNS TO THEIR QUALITY CONTROL DEPARTMENT. AESCULAP'S QC SENT THEM TO (B)(4). AESCULAP INFORMED US THAT OUR ORIGINAL GUNS WILL BE QUARANTINED FOR A YEAR. AESCULAP SENT US TWO NEW GUNS TO REPLACE THE FAULTY GUNS. AESCULAP CLAIMS THE GUNS WERE NOT WORKING CORRECTLY BECAUSE WE WERE USING BAUSCH & LOMB WIRE. MD AGREED TO TRIAL THE AESCULAP GUNS WITH AESCULAP SNARE WIRES. AESCULAP GUNS AGAIN DIDN'T WORK CORRECTLY WITH THE AESCULAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492414 TONSIL SNARE KBZ AESCULAP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR