BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER

    MDR report key: 57590 · Received October 10, 1996

    Report

    Report Number
    1527736-1996-00255
    Event Type
    Malfunction
    Date Received
    October 10, 1996
    Date of Event
    September 11, 1996
    Report Date
    October 10, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A1,2,4;B6,7;D10: INFO UNAVAILABLE. D5,6;H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    9/20/96 THE SURGEON STATED THE EZ35 WAS FIRED 4 TIMES AND THERE WAS STAPLE LINE BLEEDING ON ALL FIRINGS. THE OOZING WAS ALONG THE ENTIRE STAPLE LINE. THE SURGEON STATED THE FIRING FELT NORMAL AND ALL THE STAPLES WERE FORMED. HE USED CAUTERY TO CONTROL THE OOZING. KJB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other