BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AR ANGLED BLADE ELECTRODE INS

    MDR report key: 2171358 · Received July 18, 2011

    Report

    Report Number
    1717344-2011-00569
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE RETURN OF THE INCIDENT DEVICE HAS BEEN REQUESTED, HOWEVER, THE CUSTOMER IS NOT RELEASING THE INCIDENT DEVICE FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE DEVICE IS REC'D, OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE AND FELL INTO THE PT CAVITY. THE PIECE WAS NOT RETRIEVED FROM THE PT. THE SITE NOTIFIED THE PT OF THE ISSUE. THE PROCEDURE WAS FOR PAIN RELIEF AFTER A TOTAL KNEE REPLACEMENT THAT DEVELOPED FIBROTIC TISSUE PROBLEMS. THE SURGERY WAS PERFORMED TO BREAK UP THE FIBROUS TISSUE TO ALLEVIATE THE PT'S PAIN. THE SURGEON DID NOT PERFORM AN X-RAY, AS THE SURGEON THOUGHT IT WOULD NOT BE BENEFICIAL BECAUSE OF THE HARDWARE THAT WAS ALREADY IN THE PT'S KNEE. THE SURGEON FILTERED THE IRRIGATION FLUID FROM THE PROCEDURE SITE AND FOUND NOTHING IN THE RESULTS. THE SURGEON IS CONFIDENT THAT THE PIECE REMAINS IN THE PT. THE PIECE WAS NOT REMOVED AS IT IS PROBABLY EMBEDDED IN THE INFECTED TISSUE AND THE SURGEON OPTED NOT TO REMOVE IT FROM PT. THE CUSTOMER IS NOT RELEASING THE INCIDENT DEVICE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AR ANGLED BLADE ELECTRODE INS ARTHROSCOPIC ELECTRODE GEI COVIDIEN LP (VALLEYLAB) 0410F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other