BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP**

    MDR report key: 1891771 · Received November 5, 2010

    Report

    Report Number
    3005075853-2010-06327
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    March 13, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT HAS BEEN VOIDED AS THE DEVICE WAS FOUND TO BE REPROCESSED. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH EVIDENCE OF REPROCESSING. NO TESTING WAS PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE CLIPS STAYED OPEN AFTER FIRING, ONLY THE TIPS CLOSED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS PROLONGED THIRTY MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    THREE FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON A PATIENTS' SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND NEGATIVE RESULTS WERE OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. E4MN8J

    Patients

    Seq Age Sex Outcome Treatment
    1