BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS

    MDR report key: 350100 · Received September 4, 2001

    Report

    Report Number
    1527736-2001-04685
    Event Type
    Injury
    Date Received
    September 4, 2001
    Date of Event
    August 13, 2001
    Report Date
    August 13, 2001
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT WHEN THE DEVICE WAS USED DURING A LAPAROSCOPIC ADRENALECTOMY PROCEDURE, STAPLE LINE BLEEDING RESULTED. THE SURGEON CONVERTED TO AN OPEN PROCEDURE TO CONTROL THE BLEEDING AND COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39919 ENDOPATH ETS LINEAR CUTTERS - ENDOSCOPIC KOG ETHICON ENDO-SURGERY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention