BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, INC

    MDR report key: 417296 · Received September 16, 2002

    Report

    Report Number
    417296
    Event Type
    Injury
    Date Received
    September 16, 2002
    Date of Event
    September 6, 2002
    Report Date
    September 16, 2002
    Manufacturer
    ETHICON EDNDO-SURGERY, INC
    Product Code
    ---
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GASTRIC PARTITIONING DURING LAPAROSCOPIC GASTRIC BYPASS-STAPLER JAMMED AND MISFIRED. ATTEMPTED TO RE-APPLY NEW STAPLER ADJACENT TO MISFIRED STAPLE LINE. GASTRIC (NATURE) STAPLE LINE DEHISCENCE. RESECTED AT SECOND SURGERY 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC 1 ENDOPATH-LINEAR CUTTER ENDOSCOPY --- ETHICON EDNDO-SURGERY, INC ETS45 R4TK1T

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| O| R