BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUSE EXCAVATOR

    MDR report key: 92652 · Received May 20, 1997

    Report

    Report Number
    1932180-1997-00051
    Event Type
    Malfunction
    Date Received
    May 20, 1997
    Date of Event
    April 22, 1997
    Report Date
    April 22, 1997
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    JYH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A STAPEDECTOMY PROCEDURE, A TINY TIP OF THIS INSTRUMENT BROKE OFF. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUSE EXCAVATOR EAR EXCAVATOR JYH STORZ INSTRUMENT CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO