BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA 100-3.8 SINGLE USE LOADING UNIT

    MDR report key: 4130648 · Received September 30, 2014

    Report

    Report Number
    2647580-2014-00786
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    June 23, 2014
    Report Date
    September 18, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY.ACCORDING TO THE REPORTER:CUSTOMER STATED THAT NO STAPLE WAS FIRED OUT AND A PART OF THE TISSUE WAS CUT. THE DEVICE WAS NOT FULLY CYCLED AND THE DEVICE COULD NOT BE FIRED. THERE WAS UNANTICIPATED TISSUE LOSS. THEN THE DEVICE WAS REPLACED BY A NEW ONE WHICH WORKED WELL. SURGERY TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. LAST KNOWN PATIENT STATUS REPORTED AS GOOD. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607298 GIA 100-3.8 SINGLE USE LOADING UNIT DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC GIA10038L P3G0490X

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability