BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON

    MDR report key: 2502471 · Received March 20, 2012

    Report

    Report Number
    2502471
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 20, 2012
    Manufacturer
    BOSS INSTRUMENTS, LTD
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    SURGICAL TECH HANDED THE SURGEON A KERRISON (RONGUER). BEFORE HE USED IT, HE NOTICED IT WAS BROKEN. INSTRUMENT WAS HANDED OFF THE FIELD AND GIVEN TO THE INSTRUMENT WORKROOM TECH. INSTRUMENT THEN GIVEN TO THE MATERIALS COORDINATOR. NO INJURY TO PATIENT. THE HANDLE OF THE INSTRUMENT APPEARED TO HAVE BROKEN AT THE "WELD" SITE. AT NO TIME DID THE INSTRUMENT COME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERRISON INSTRUMENT, RONGUER HAE BOSS INSTRUMENTS, LTD 70-0330 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR