BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECKER RONGEURS

    MDR report key: 670884 · Received January 31, 2006

    Report

    Report Number
    670884
    Event Type
    Malfunction
    Date Received
    January 31, 2006
    Date of Event
    November 16, 2005
    Report Date
    January 25, 2006
    Manufacturer
    CODMAN
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE A SMALL PIECE OF THE DECKER PITUITARY RONGEUR BROKE OFF. C-ARM WAS USED TO REMOVE THE PIECE FROM THE PT. ALL REUSABLE SURGICAL INSTRUMENTS ARE ON A REGULAR PREVENTATIVE MAINTENANCE SCHEDULE. POSTOPERATIVELY, THE PT DID WELL AND HE WAS DISCHARGED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DECKER RONGEURS RONGEURS HAE CODMAN 53-4000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other