BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTO SUTURE PREMIUM PLUS CEEA 25MM

    MDR report key: 295793 · Received September 12, 2000

    Report

    Report Number
    295793
    Event Type
    Other
    Date Received
    September 12, 2000
    Date of Event
    July 24, 2000
    Report Date
    August 14, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ESOPHAGEAL REPAIR FOR A PERIESOPHAGEAL HERNIA, A EEA 25 AUTO SUTURE STAPLER WAS USED. REPORTEDLY, THE DEVICE DID NOT FIRE PROPERLY. THE STAPLES DID NOT APPEAR TO CLOSE, THEREFORE, DID NOT SECURE THE TISSUE. DUE TO SHORTENING OF THE DISTAL ESOPHAGUS THE PT HAD TO BE TRANSFERED TO ANOTHER FACILITY FOR A THORACIC-ABDOMINAL APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM PLUS CEEA 25MM DISP. SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP NA P9K32

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other