BEUDAMED
    FDA Adverse Event Summary report: N

    CERTUS 140 2.45 GHZ ABLATION SYSTEM

    MDR report key: 5460301 · Received February 25, 2016

    Report

    Report Number
    3008769756-2016-00005
    Date Received
    February 25, 2016
    Date of Event
    January 28, 2016
    Report Date
    February 25, 2016
    Manufacturer
    NEUWAVE MEDICAL, INC
    Product Code
    NEY
    PMA / PMN Number
    K113237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE HAS BEEN RETURNED TO NEUWAVE MEDICAL. A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE PROBE MET ALL SPECIFICATIONS AND PASSED ALL MANUFACTURING TESTS. SYSTEM LOGS WERE REVIEWED AND INDICATED THAT THE SYSTEM AND PROBE FUNCTIONED NORMALLY DURING THE PROCEDURE. THE PHYSICAL INVESTIGATION CONCLUDES THAT THE CERAMIC PORTION OF THE PROBE TIP - BETWEEN THE METAL TROCAR AND THE METAL SHAFT - WAS BROKEN. THIS SUPPORTS THE CONCLUSION THAT LATERAL FORCES WERE APPLIED TO THE CERAMIC PORTION OF THE PROBE TIP. IT IS SUSPECTED THAT THESE LATERAL FORCES RESULTED IN SUFFICIENT FORCE TO CAUSE THE CERAMIC TO BREAK. ADDITIONALLY, THE BREAK PATTERN ON THE SUSPECT PROBE IS CONSISTENT WITH LATERAL FORCE APPLIED TO THE CERAMIC.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A CERTUSPR 15CM PROBE TO ABLATE AN OSTEOID OSTEOMA IN A PATIENT OF UNKNOWN AGE AND GENDER. A BONE INTRODUCER WAS USED TO GAIN ACCESS TO THE TARGET. THE CERTUS PR PROBE WAS INSERTED THROUGH THE INTRODUCER INTO THE TARGET. THE PROBE WAS USED TO ABLATE AT 30 WATTS FOR A TOTAL OF 91 SECONDS WITHOUT ISSUE. THE INTRODUCER WAS THEN ADVANCED BACK INTO THE TARGET. WHEN THE PR PROBE WAS REMOVED, THE TIP WAS NOT ATTACHED TO THE PROBE SHAFT. THE INTRODUCER WAS REMOVED FROM THE BONE AND THE CERAMIC PORTION OF THE PROBE TIP WAS VISIBLE. THE CERAMIC WAS REMOVED, BUT THE METALIC PROBE TIP REMAINED IN THE TARGET TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117863 CERTUS 140 2.45 GHZ ABLATION SYSTEM MICROWAVE ABLATION SYSTEM NEY NEUWAVE MEDICAL, INC PR ABLATION PROBE NM15110023

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other