BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH THROCIC ENDO LINEAR CUTTER WITH S/L

    MDR report key: 153424 · Received February 27, 1998

    Report

    Report Number
    1527736-1998-00541
    Event Type
    Injury
    Date Received
    February 27, 1998
    Date of Event
    January 30, 1998
    Report Date
    January 30, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49078. DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LUNG VOLUME REDUCTION THE SURGEON FIRED THE DEVICE APPROXIMATELY 4 TIMES AND ON THE FIFTH FIRING ONE STAPLE LINE HAD STAPLES AND THE OPPOSITE SIDE DID NOT HAVE STAPLES. IT WAS THE SURGEON'S OPINION THE CARTRIDGE ONLY HAD STAPLES IN ONE SIDE. THE PT WAS OPENED TO CONTROL BLEEDING AND BLOOD LOSS WAS ESTIMATED AT 2 UNITS. THE PT RECEIVED 2 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THROCIC ENDO LINEAR CUTTER WITH S/L EZ45G GAG ETHICON ENDO-SURGERY, INC. NA K48J4R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R