BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLUCCI MICRO SCISSORS

    MDR report key: 1183163 · Received September 17, 2008

    Report

    Report Number
    1183163
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 17, 2008
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A ROUTINE TYMPANOPLASTY WITHOUT DIFFICULTY. DURING THE ROUTINE INSTRUMENT CLEANING IT WAS NOTED THAT THE BELLUCCI MICRO SCISSORS HAD A MISSING BLADE. THE SURGEON CALLED THE PATIENT'S FAMILY AS THEY WERE ALREADY DISCHARGED HOME. THE SURGEON INFORMED THE PARENTS OF THE ISSUE AND INSTRUCTED THEM TO RETURN FOR A X-RAY. THE SURGEON STATED THAT HE DOES NOT FEEL THE BLADE IS IN THE PT'S EAR, AS HE WOULD HAVE NOTICED IT ESPECIALLY SINCE WORKING UNDER A MICROSCOPE. PATIENT DID RETURN FOR A SKULL SERIES WHICH WAS NEGATIVE FOR RADIOPAQUE METALLIC FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELLUCCI MICRO SCISSORS SCISSORS, MICRO LRW KARL STORZ ENDOSCOPY-AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR NO OTHER THERAPIES| NO OTHER THERAPIES