BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 2170072 · Received July 13, 2011

    Report

    Report Number
    2647580-2011-00458
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 3, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: THE DEVICE WAS USED TO DO AN ANASTOMOSIS DURING COLON SURGERY. WHILE STIMULATING AND TURNING OFF THE BUTTON, THE SURGEON FOUND THAT THERE WERE NO SEAM PINS AND AN ANASTOMOTIC STOMA OPENED. UPON TAKING OUT THE INSTRUMENT, THE SURGEON FOUND THAT INSIDE IT, THERE WERE NO SEAM PINS. ANOTHER DEVICE WAS USED TO FINISH THE ANASTOMOSIS. THE PATIENT IS DOING WELL WITH NO INJURIES. THE DEVICE FAILURE RESULTED IN BLOOD LOSS THAT WAS NOT GREATER THAN 250CC. UNANTICIPATED TISSUE LOSS OCCURRED AND OPERATIVE TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW USSC PUERTO RICO P0H0356H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| S