BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL REDUCER 5/10/12MM 3-HOLE

    MDR report key: 649450 · Received December 5, 2005

    Report

    Report Number
    1317214-2005-00126
    Event Type
    Malfunction
    Date Received
    December 5, 2005
    Date of Event
    November 4, 2005
    Report Date
    December 4, 2005
    Manufacturer
    CONMED CORP.
    Product Code
    FBQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE 10MM SEAL WAS PUSHED INTO THE PT'S ABDOMEN. IT WAS RETRIEVED. THERE WAS NO PT INJURY AND THE PROCEDURE WAS NOT ALTERED. THE SURGICAL TIME WAS EXTENDED TO RETRIEVE THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL REDUCER 5/10/12MM 3-HOLE SURGICAL TROCAR SYSTEM REDUCER FBQ CONMED CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN