BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM

    MDR report key: 974052 · Received January 4, 2008

    Report

    Report Number
    2027111-2007-00083
    Event Type
    Other
    Date Received
    January 4, 2008
    Date of Event
    October 17, 2007
    Report Date
    November 2, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DSS
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 1021374. PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN PRODUCT IS RETURNED, EVALUATION WILL BE COMPLETED AND FINAL REPORT WILL BE SUBMITTED. IN THE ABSENCE OF THIS SUBJECT DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE AND FAILURE MODE. WE HAVE REVIEWED THE DEVICE HISTORY RECORD OF THIS DEVICE AND FOUND NO DEVIATIONS OR DISCREPANCIES IN OUR STANDARD MANUFACTURING AND TESTING PROCEDURES. AS A RESULT WE ARE CONCLUDING OUR INVESTIGATION AND CLOSING THIS FILE.

    Description of Event or Problem · 1

    "AT THE END OF THE PROCEDURE WHEN THE MD WAS REMOVING CLAMP FROM THE VEIN GRAFT, IT FELL APART INTO THE CHEST CAVITY." THE PATIENT HAS EXHIBITED NO UNTOWARD EFFECTS UP TO THIS 5TH POST-OP DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM SURGICAL SPRING CLIPS DSS APPLIED MEDICAL RESOURCES G-6000 1023180

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other