BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTUS 140 2.45 GHZ ABLATION SYSTEM

    MDR report key: 4193052 · Received October 21, 2014

    Report

    Report Number
    3008769756-2014-00004
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 20, 2014
    Product Code
    GEI
    PMA / PMN Number
    K100744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABLATION PROBE IN QUESTION HAS NOT YET BEEN RETURNED TO NEUWAVE FOR EVALUATION. A REVIEW OF THE PROBE LOT HISTORY RECORD INDICATES THAT THIS PROBE MET ALL MANUFACTURING/PERFORMANCE SPECIFICATIONS. NEUWAVE WILL CONTINUE TO WORK WITH THE PHYSICIAN TO OBTAIN THE PROBE. IF THE PROBE IS RETURNED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING ONE 15CM CERTUSPR PROBE TO ABLATE AN OSTEOID OSTEOMA. THE PHYSICIAN PLACED A RIGID METALLIC INTRODUCER THROUGH THE OVERLYING SOFT TISSUES AND INTO THE BONE TO OBTAIN ACCESS TO THE TARGET TISSUE. THE CERTUSPR PROBE WAS PLACED THROUGH THE INTRODUCER AND POSITIONED AT THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO REPOSITION THE ABLATION PROBE AND DETERMINED THAT THE PROBE TIP WAS NO LONGER INTACT. THE PROBE WAS REMOVED AND IT WAS CONFIRMED THAT THE PROBE TIP REMAINED IN THE BONE. A SECOND CERTUSPR PROBE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669474 CERTUS 140 2.45 GHZ ABLATION SYSTEM ELECTROSURGICAL CUTTING/COAGULATION TOOL GEI PR ABLATION PROBE NM14070011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other