BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE

    MDR report key: 2093779 · Received May 12, 2011

    Report

    Report Number
    MW5020588
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    COVIDEN / TYCO HEALTHCARE
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAPLER WAS NEEDED TO CLOSE EXCISION SITE OF MALIGNANT BACK LESIONS. FIRST STAPLER MISFIRED, TWO OTHER STAPLERS MISFIRED AND JAMMED DURING USE. SOME STAPLES APPEARED CROOKED ON INCISION - REMOVED. OTHER STAPLER USED FINE, 3 DEFECTIVE STAPLERS REMOVED FROM ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MULTIFIRE PREMIUM STAPLER WIDE GDW COVIDEN / TYCO HEALTHCARE 059037 N1A0924
    2 AUTO SUTURE MULTIFIRE PREMIUM STAPLER REGULAR GDW COVIDIEN / TYCO HEALTHCARE 059035 N1B0201

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR