BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM CEEA 25

    MDR report key: 16789 · Received August 29, 1994

    Report

    Report Number
    16789
    Event Type
    Injury
    Date Received
    August 29, 1994
    Date of Event
    April 12, 1994
    Report Date
    May 5, 1994
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A COLON RESECTION, MD NOTED UNFAMILIAR SOUND WHEN EEA STAPLER ACTIVATED. EEA STAPLER WAS REMOVED AND EXAMINED BY MD TO DETERMINE IF IT MIS-FIRED. NO DETERMINATION COULD BE MADE. PATIENT THEN UNDERWENT DOUBLE BARREL COLOSTOMY, UNPLANNED, THAT ADDED THREE HOURS TO CASE. NO EVIDENCE OF STAPLES WAS SEEN ON X-RAYS. VERBAL REPORT GIVEN TO MANUFACTURER APRIL 12, 1994.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM CEEA 25 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP. AUTO SUTURE PREMIUM CEEA 25 P2L85K

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R| S