BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, INC

    MDR report key: 355831 · Received October 12, 2001

    Report

    Report Number
    355831
    Event Type
    Injury
    Date Received
    October 12, 2001
    Date of Event
    September 21, 2001
    Report Date
    October 12, 2001
    Manufacturer
    ETHICON ENDOSURGERY INC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSPITAL IN 2001 WITH ABDOMINAL PAIN. INITIAL SURGERY PERFORMED 2 DAYS LATER FOR PERFORATED VISCUS. PT WAS TAKEN BACK TO SURGERY 1 WEEK LATER FOR REPAIR OF ANASTOMOTIC DEHISCENCE SECONDARY TO STAPLE MISFIRE WITH TRUNCAL VAGOTOMY. DURING PROCEDURE A STAPLE WAS CAREFULLY REMOVED FROM PT AND RETURNED TO ETHICON FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46154 ETHICON ENDO-SURGERY, INC 1 PROXIMATE RELOADABLE LINEAR CUTTER GAG ETHICON ENDOSURGERY INC GIA REFTCT75 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention