BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CDH 29

    MDR report key: 134857 · Received December 31, 1996

    Report

    Report Number
    134857
    Event Type
    Malfunction
    Date Received
    December 31, 1996
    Date of Event
    October 28, 1996
    Report Date
    October 30, 1996
    Manufacturer
    ETHICON ENDOSURGERY MC #23
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAPLER MISFIRED-STAPLES DID NOT TIGHTEN. PROCEDURE WAS COMPLETED WITH USE OF SUTURES BECAUSE STAPLES DID NOT HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CDH 29 CURVED INTRALUMINAL STAPLER GAG ETHICON ENDOSURGERY MC #23 * H41H45

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other