BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS ENDOSCOPIC LINEAR CUTTER

    MDR report key: 217985 · Received April 5, 1999

    Report

    Report Number
    1527736-1999-01920
    Event Type
    Malfunction
    Date Received
    April 5, 1999
    Date of Event
    March 5, 1999
    Report Date
    March 8, 1999
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE LAPAROSCOPIC HAND ASSISTED SIGMOID COLON RESECTION, THE SURGEON WAS USING THE TSG45 STAPLER. THE STAPLER WAS USED TO TRANSECT THE SIGMOID COLON AND THE SIGMOID MESOCOLON. THE INSTRUMENT WAS FIRED A TOTAL OF 6 TIMES. WHEN USING THE VASCULAR CARTRIDGE TO TRANSECT THE SIGMOID MESOCOLON, POOR HEMOSTASIS WAS ACHIEVED ON THREE FIRINGS. BLEEDING WAS CONTROLLED USING A LAPAROSCOPIC CLIP APPLIER. AFTER THE THIRD INCIDENT, THE SURGEON CHANGED TO A COMPETITIVE STAPLER TO COMPLETE THE PROCEDURE WITHOUT HEMOSTATSIS ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS ENDOSCOPIC LINEAR CUTTER LINEAR CUTTERS - ENDOSCOPIC KOG ETHICON ENDO-SURGERY NA M4DF1A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other