BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 2832070 · Received October 26, 2012

    Report

    Report Number
    2027111-2012-00320
    Date Received
    October 26, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 26, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    LAPAROSCOPIC CHOLECYSTECTOMY - "THE CLIPS DO NOT FULLY CLOSE AFTER FIRING." PT STATUS: "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE FZP APPLIED MEDICAL CA090 1171480

    Patients

    Seq Age Sex Outcome Treatment
    1