BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER 75MM

    MDR report key: 559213 · Received May 11, 2004

    Report

    Report Number
    1527736-2004-01351
    Event Type
    Malfunction
    Date Received
    May 11, 2004
    Date of Event
    April 16, 2004
    Report Date
    April 16, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN OESOPHAGO-GASTRECTOMY PROCEDURE, AFTER FIRING THE TLC AND INSPECTING THE STAPLE LINE, STAPLES SHOWED THEY DID NOT CLOSE. THEY WERE AT AN UNUSUAL ANGLE. TLC WAS THEN RELOADED WITH A NEW CARTRIDGE. IT WAS EVEN STIFFER TO FIRE THAN THE FIRST TIME. STAPLING HAD TO BE ABANDONED AND MANUAL SUTURING HAD TO BE DONE. THIS DELAYED THE PROCEDURE AS THE SURGEON HAD TO OVERRIDE THE LINEAR CUTTER, PUT THE CLAMPS ON AND HAND SEW AND CUT MANUALLY. O.R TIME WAS EXTENDED 15-20 MINUTES. PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER 75MM LINEAR CUTTERS-CONVENTIONAL GAG ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA U4YV1P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other