BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 3930391 · Received July 11, 2014

    Report

    Report Number
    2027111-2014-00297
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 11, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT 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

    UNKNOWN- "CLIPS DO NOT CLOSE. CONTINUING BLEEDING, REMOVAL OF CLIPS PLACED AND USE OF ANOTHER DEVICE."PATIENT STATUS: OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406189 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX CODE:FZP FZP APPLIED MEDICAL CA090 1216197

    Patients

    Seq Age Sex Outcome Treatment
    1