BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 436850 · Received January 9, 2003

    Report

    Report Number
    1527736-2003-00035
    Event Type
    Death
    Date Received
    January 9, 2003
    Date of Event
    December 17, 2002
    Report Date
    December 17, 2002
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROTOMY WITH EXCISION OF RETROPERITONEAL MASS FOUR INSTRUMENTS JAMMED AFTER APPROX 14 CLIPS WERE FIRED FROM EACH DEVICE. TWO OF THE FOUR DEVICES ARE BEING RETURNED. THE PT RECEIVED 20 UNITS OF BLOOD. PT EXPIRED DUE TO BLOOD LOSS.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT DURING A LAPAROTOMY WITH EXCISION RETROPERITONEAL MASS FOUR INSTRUMENTS JAMMED AFTER APPROXIMATELY 14 CLIPS WERE FIRED FROM EACH DEVICE. TWO OF THE FOUR DEVICES ARE BEING RETURNED. THE PT RECEIVED 20 UNITS OF BLOOD. PT EXPIRED DUE TO BLOOD LOSS. ADDITIONAL EVENT INFO WAS PROVIDED, SURGEON STATED THAT DEVICES DID NOT CAUSE PT DEATH, THE SURGEON WAS FRUSTRATED AS THE DEVICES JAMMED DURING USE BUT WERE NOT A CONTRIBUTING FACTOR TO THE DEATH OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MULTIPLE CLIP APPLIER CONVENTIONAL CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA R4U500

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death