BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 2674661 · Received July 21, 2012

    Report

    Report Number
    2027111-2012-00205
    Date Received
    July 21, 2012
    Date of Event
    July 5, 2012
    Report Date
    July 23, 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. 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

    CHOLECYSTECTOMY - "LOT # 1162255, THE DOCTOR COULD ONLY SHOOT 2 STAPLES. LOT # 1163377, THE DOCTOR COULD ONLY SHOOT 8 STAPLES. LOT #, 1165540 WHEN THE DOCTOR FIRED THE STAPLES, THESE WERE NOT PARALLEL. THE DOCTOR DECIDED TO USE A DIFFERENT INSTRUMENT." 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 1162255

    Patients

    Seq Age Sex Outcome Treatment
    1