BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLINCH II 5MM INSTRUMENT

    MDR report key: 1030267 · Received April 15, 2008

    Report

    Report Number
    2647580-2008-00223
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K903205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SUBMITTED: 4/15/08.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE TIP OF THE ENDOCLINCH BROKE OFF AS THE SURGEON TRIED TO REMOVE THE GALLBLADDER. NO PT INJURY WAS REPORTED. PROCEDURE: UNK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLINCH II 5MM INSTRUMENT SURGICAL HAND INSTRUMENT GCJ PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK