BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE

    MDR report key: 2963932 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00660
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING 21 CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DID THE "CLIP" CUT THE VESSEL OR THE "JAWS" CUT THE VESSEL? THE INCIDENT REPORT STATED THAT THE CLIP CUT THE VESSEL. WHAT WAS THE QUANTITY OF BLOOD LOSS? THERE WAS MINIMAL BLOOD LOSS AS ANOTHER DEVICE WAS USED TO CLIP THE VESSEL. WHAT INTERVENTION WAS REQUIRED? THERE WAS NO INTERVENTION REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY USER FACILITY MEDWATCH# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69357 CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA J4CN4F

    Patients

    Seq Age Sex Outcome Treatment
    1