BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOSUTURE

    MDR report key: 516129 · Received February 27, 2004

    Report

    Report Number
    MW1031383
    Event Type
    Other
    Date Received
    February 27, 2004
    Date of Event
    February 25, 2004
    Report Date
    February 27, 2004
    Manufacturer
    U.S. SURGICAL CORP
    Product Code
    GAG
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING THE AUTOSUTURE V-30 ROTICULATOR STAPLER TO STAPLE AND CUT THE PULMONARY VEIN. THE STAPLES DID NOT CLOSE OR STAPLE THE TISSUE. THE PHYSICIAN HAD TO PICK THE OPEN STAPLES OFF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE V-30 ROTICULATOR GAG U.S. SURGICAL CORP 30-V3 P1G271

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other