BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON

    MDR report key: 320644 · Received March 13, 2001

    Report

    Report Number
    MW1021319
    Event Type
    Other
    Date Received
    March 13, 2001
    Date of Event
    February 14, 2001
    Report Date
    February 20, 2001
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KDW
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE 35MM VASCULAR STAPLER WOULDN'T FIRE ON THE FOURTH RELEAD. THE ENDOPOUCH CAME APART WHEN INSERTED INTO THE ABDOMEN. A SECOND ENDOPOUCH CAME APART WHEN INSERTED INTO THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11048 ETHICON ENDOPOUCH PRO KDW ETHICON ENDO-SURGERY, INC. PRO46 00K568
    11140 ETHICON ETS ENDOSCOPIC LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. TSW35 35MM VASCULAR/THIN N4JV5K
    11141 ETHICON ENDOPOUCH PRO KDW ETHICON ENDO-SURGERY, INC. PRO46 00J527

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other