BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA MED

    MDR report key: 1821709 · Received August 31, 2010

    Report

    Report Number
    3005075853-2010-04978
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 5, 2010
    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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    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 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 RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT, IT WAS DISCOVERED THAT A DOWNSTREAM OCCLUSION ALARM OCCURRED ONCE DURING INFUSION THAT CAUSED AN INTERRUPTION DURING DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 6.63.90, CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A CUTTING CLIP. NO ADDITIONAL DETAILS PROVIDED BY THE CUSTOMER. THERE WAS INTRA OPERATIVE BLEEDING. NO POST OPERATIVE PATIENT CONSEQUENCES DESCRIBED. NO FURTHER INFORMATION PROVIDED DESPITE SEVERAL ATTEMPTS. UNKNOWN HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP*MCA MED CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA G4RZ02

    Patients

    Seq Age Sex Outcome Treatment
    1