BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 3050193 · Received April 5, 2013

    Report

    Report Number
    2027111-2013-00128
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    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. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    "DR (B)(6), 1ST CLIP DID NOT CLOSE COMPLETELY. DOCTOR ASKED FOR NEW DEVICE. NEW DEVICE WAS OPENED AND WORKED JUST FINE." PATIENT STATUS: "STABLE, DISCHARGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141705 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1186685

    Patients

    Seq Age Sex Outcome Treatment
    1