BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON

    MDR report key: 238078 · Received August 31, 1999

    Report

    Report Number
    238078
    Event Type
    Death
    Date Received
    August 31, 1999
    Date of Event
    May 24, 1999
    Report Date
    July 1, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ETHICON LINEAR STAPLER USED IN ABDOMINAL SURGERY. SUTURES (STAPLER) FAILED, RESULTING IN ADD'L SURGERIES, PROLONGED STAYS AND POSSIBLY DEATH. SEVERAL PTS, VARIOUS SURGEONS. PT #1 DIED ON 6/2/99.

    Description of Event or Problem · 2

    ETHICON LINEAR STAPLER USED IN ABDOMINAL SURGERY. SUTURES (STAPLES) FAILED, RESULTING IN ADD'L SURGERIES, PROLONGED STAYS AND POSSIBLY DEATH. SEVERAL PTS, VARIOUS SURGEONS. DATE OF EVENT 6/14/99.

    Description of Event or Problem · 3

    ETHICON LINEAR STAPLER USED IN ABDOMINAL SURGERY. SUTURES (STAPLES) FAILED, RESULTING IN ADD'L SURGERIES, PROLONGED STAYS AND POSSIBLY DEATH. SEVERAL PTS, VARIOUS SURGEON. DATE OF EVENT 6/2/99 AND 6/28/99.

    Description of Event or Problem · 4

    ETHICON LINER STAPLER USER IN ABDOMINAL SURGERY. SUTURES (STAPLES) FAILED, RESULTING IN ADD'L SURGERIES, PROLONGED STAYS AND POSSIBLY DEATH. SEVERAL PTS, VARIOUS SURGEONS. DATE OF EVENT: 3/10/99.

    Description of Event or Problem · 5

    ETHICON LINEAR STAPLER USED IN ABDOMINAL SURGERY. SUTURES (STAPLES) FAILED, RESULTING IN ADD'L SURGERIES, PROLONGED STAYS AND POSSIBLY DEATH. SEVERAL PTS, VARIOUS SURGEONS. DATE OF EVENT 6/14/99 AND 6/27/99.

    Description of Event or Problem · 6

    ETHICON LINEAR STAPLER USED IN ABDOMINAL SURGERY. SUTURES (STAPLES) FAILED, RESULTING IN ADD'L SURGERIES, PROLONGED STAYS AND POSSIBLY DEATH. SEVERAL PTS, VARIOUS SURGEONS. DATE OF EVENT: 6/19/99.

    Description of Event or Problem · 7

    ETHICON LINEAR STAPLER USED IN ABDOMINAL SURGERY. SUTURES (STAPLES) FAILED, RESULTING IN ADD'L SURGERIES, PROLONGES STAYS AND POSSIBLY DEATH. SEVERAL PTS, VARIOUS SURGEONS. DATE OF EVENT 4/22/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ETHICON LINEAR STAPLER GAG ETHICON ENDO-SURGERY, INC. TLH90,TLH90,AX55G,AX55G MORE L4CH7R,M4DW6B,M4DT23 MORE

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death| H| L
    2 * Hospitalization| L
    3 * Hospitalization| L
    4 * Hospitalization| L
    5 * Hospitalization| L
    6 * Hospitalization| L
    7 * Hospitalization| L