BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ DAVIS MOUTH GAG

    MDR report key: 40653 · Received September 6, 1996

    Report

    Report Number
    1932180-1996-00070
    Event Type
    Malfunction
    Date Received
    September 6, 1996
    Date of Event
    August 7, 1996
    Report Date
    August 8, 1996
    Manufacturer
    STORZ INSTRUMENT COMPANY
    Product Code
    KBN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY PROCEDURE, THE MECHANISM THAT CONTROLS THE LOCK ON THIS MOUTH GAG WAS NOT WORKING CORRECTLY AND A CRACK COULD BE SEEN. ANOTHER GAG WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ DAVIS MOUTH GAG MOUTH GAG KBN STORZ INSTRUMENT COMPANY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA