BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO SUTURE PREMIUM PLUS CEEA 28

    MDR report key: 38121 · Received September 10, 1996

    Report

    Report Number
    1219161-1996-00045
    Event Type
    Death
    Date Received
    September 10, 1996
    Report Date
    September 10, 1996
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    10/23/96 THE FOLLOWING "SUMMARY OF FINDINGS" WAS INADVERTENTLY SUBMITTED UNDER CO'S FOLLOW-UP REPORT #1. PLEASE DISREGARD THIS INFO AS IT DOES NOT PERTAIN TO THIS REPORT. SUMMARY OF FINDINGS: CO HAS DETERMINED THAT DURING THORACIC PROCEDURES DUE TO THE LOCATION AND METHOD OF USE, THE USER CAN INADVERTENTLY DEPRESS THE RELEASE BUTTON WHILE CLAMPING THE APPROXIMATING LEVER. THIS CONDITION HAS BEEN ADDRESSED IN CURRENT PRODUCTION WITH PROCESS MODIFICATIONS THAT PREVENT THE JAWS FROM CLOSING WITH THE CARTRIDGE NOT FULLY SEATED.

    Description of Event or Problem · 1

    THE DEVICE WAS APPLIED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE ANASTOMSIS LEAKED AND CAUSED PERITONITIS. THE PT DIED AT AN UNSPECIFIED TIME POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM PLUS CEEA 28 DISPOSABLE STAPLER GAG UNITED STATES SURGICAL CORP. NA U5J70

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death A DIFFERENT PREMIUM PLUS CEEA ANVIL WAS USED WITH| THE INSTRUMENT.