BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM

    MDR report key: 958321 · Received April 25, 2007

    Report

    Report Number
    2027111-2007-00023
    Event Type
    Other
    Date Received
    April 25, 2007
    Date of Event
    February 26, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DSS
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WITH THE FEMALE JAW. CONCLUSION/CORRECTIVE ACTION: THE CAUSE OF THE INCIDENT WAS INVESTIGATED BUT CANNOT BE DETERMINED WITHOUT ADDITIONAL INFO. ENGINEERING WAS UNABLE TO DUPLICATE THE REPORTED INCIDENT USING A FULLY ACTUATED MODEL A3218 CLIP APPLICATOR. THE TYPE OF CLIP APPLICATOR USED, THE AMOUNT OF FORCE APPLIED AND OTHER FACTORS ARE NEEDED TO UNDERSTAND THE CONDITION THE CLIP WAS IN.

    Description of Event or Problem · 1

    "DURING CORONARY ARTERY BY-PASS GRAFTING G-6000 APPLIED WITH APPLIER AND SPRING CLIP BROKE AT THE ROUND HUB WHERE APPLIER IS PLACED - HUB AND SPRING CAME APART - ALL PIECES RETRIEVED FROM PT."

    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 1024039

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other