BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLINCH II 5MM INSTRUMENT

    MDR report key: 3222106 · Received July 1, 2013

    Report

    Report Number
    1219930-2013-00504
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    HDA
    PMA / PMN Number
    K903205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING PROCEDURE, THE DEVICE WAS BROKEN AT AROUND THE HINGE OF THE DISTAL END. NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE. NOTHING FELL INTO CAVITY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297662 ENDO CLINCH II 5MM INSTRUMENT SINGLE USE LAPAROSCOPIC HAND INSTRU HDA COVIDIEN, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1