BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER

    MDR report key: 2675721 · Received July 25, 2012

    Report

    Report Number
    MW5026294
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Date of Event
    July 23, 2012
    Report Date
    July 25, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDO GIA ULTRA UNIVERSAL STAPLER USED TO CLOSE BRONCHUS DURING RIGHT THORACOTOMY WITH WEDGE RESECTION. STAPLER MALFUNCTIONED AND STAPLE DID NOT DEPLOY. NO INJURY. AREA OF RESECTION (BRONCHUS) WAS CLOSED BY HAND USING 4-0 VICRYL SUTURE INSTEAD OF USING STAPLES. PRODUCT IS HELD FOR DISTRIBUTOR REP, (B)(4), TO PICK UP AS OF 07/25/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER REF # EGIAUSTND STAPLER GDW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other