BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM

    MDR report key: 851165 · Received May 16, 2007

    Report

    Report Number
    2027111-2007-00027
    Event Type
    Other
    Date Received
    May 16, 2007
    Date of Event
    February 19, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DSS
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: PIECES FROM FOUR OR FIVE DIFFERENT SPRING CLIP UNITS WERE RETURNED AND VISUALLY INSPECTED. THE BODY FEMALE COMPONENT, IS THE ONLY BROKEN COMPONENT RETURNED. EACH OF THE RETURNED BODY FEMALE COMPONENTS SPLIT IN A DIFFERENT WAY; BUT MOST ARE SPLIT BELOW WHERE THE BODY FEMALE SNAP FITS WITH THE FEMALE JAW. CONCLUSION/CORRECTIVE ACTION: THE CAUSE OF THE INCIDENT WAS INVESTIGATED BUT CANNOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION. THE TYPE OF CLIP APPLICATOR USED, THE AMOUNT OF FORCE APPLIED AND OTHER FACTORS ARE NEEDED TO UNDERSTAND THE CONDITION THE CLIP WAS IN. ALSO, SINCE THESE ARE NON-STERILIZED CLIPS, THE METHOD OF STERILIZATION IS UNKNOWN. ENGINEERING WAS UNABLE TO DUPLICATE THE REPORTED INCIDENT WITH THE SAME MODEL CLIPS SUBJECTED TO 1 GAMMA RADIATION STERILIZATION CYCLE OF 25-40KGY USING A FULLY ACTUATED MODEL A3218 CLIP APPLICATOR.

    Description of Event or Problem · 1

    "DR. APPLIED THE VASCULAR CLAMP INTO THE LEFT INTERNAL MAMMARY ARTERY, WHEN IT BROKE INTO PIECES. HE NEEDED TO EXPLORE THE CHEST CAVITY TO LOOK FOR THE BROKEN PIECES."

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| O