BEUDAMED
    FDA Adverse Event Summary report: N

    PROXIMATE

    MDR report key: 1970631 · Received May 18, 2010

    Report

    Report Number
    1970631
    Date Received
    May 18, 2010
    Date of Event
    April 29, 2010
    Report Date
    May 18, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEONS WERE PERFORMING A WHIPPLE PROCEDURE. THE ATTENDING FIRED THE STAPLER, AND THE RESIDENT WAS STABILIZING THE DEVICE. THE LINEAR CUTTER DELIVERS TWO DOUBLE-STAGGERED ROWS OF STAPLES WHILE SIMULTANEOUSLY DIVIDING THE TISSUE BETWEEN THE ROWS. THERE'S A CUTTING BLADE THAT TRAVELS BETWEEN THE TWO ROWS OF STAPLES. THE RESIDENT SAID HE HAD HIS THUMB IN A DIVOT IN THE SHAFT, AND AS THE DEVICE WAS FIRED, THE BLADE CUT HIS THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. TLC75 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES