BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 2625885 · Received June 14, 2012

    Report

    Report Number
    2027111-2012-00158
    Date Received
    June 14, 2012
    Date of Event
    June 8, 2012
    Report Date
    June 14, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    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

    NEPHRECTOMY: "IN PREVIOUS SURGERIES, MULTIPLE CLIP APPLIERS USED, DETECTING THE SAME ERROR IN THE SAME BATCH. I'VE ATTENDED THE SURGERY. LOT 1162253 THE ENTIRE CLIP DOES NOT CLOSE, FALL OUT OF PLACE, THE ARMS OF THE CLIPS ARE NOT UNITED = LOT 1162253. SAME SURGERY, AFTER TESTING THE PREVIOUS BATCH, THEY NOW USED LOT 1162254, FIRED THE FIRST TIME, THE CLIPS DID NOT LOAD, THEY TRIED 8 OR 9 TIMES, BUT THE CLIPS DID NOT LOAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1162253

    Patients

    Seq Age Sex Outcome Treatment
    1