BEUDAMED
    FDA Adverse Event Summary report: N

    CERTUS 140 2.45 GHZ ABLATION SYSTEM

    MDR report key: 5499294 · Received March 14, 2016

    Report

    Report Number
    3008769756-2016-00006
    Date Received
    March 14, 2016
    Date of Event
    February 16, 2016
    Report Date
    March 14, 2016
    Manufacturer
    NEUWAVE MEDICAL, INC
    Product Code
    NEY
    PMA / PMN Number
    K113237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 CONFIRMED THE SYSTEM SETTINGS AND ERROR MESSAGE NOTED IN THE NARRATIVE. PHYSICAL EVALUATION OF THE RETURNED PROBE IS ONGOING. AN UPDATE TO THIS REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PROBE TIP BREAKS WERE CONFIRMED BY THE INVESTIGATION. THE PROBE TROCARS/TIPS WERE NOT RETURNED. THE ROOT CAUSE COULD NOT BE DETERMINED. BOTH PHYSICAL AND THERMAL DAMAGE TO THE PROBE WAS EVIDENT. DISTAL COMPONENTS MAY HAVE BEEN BROKEN DUE TO EXCESSIVE MECHANICAL FORCE OR THERMAL BREAKDOWN DUE TO EXCESSIVELY HIGH LOCAL TEMPERATURES AT THE TROCAR.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING TWO PR15 PROBES TO ABLATE A LESION IN THE LIVER OF A PATIENT OF UNKNOWN AGE AND GENDER. DURING THE PLACEMENT OF THE PROBE CONNECTED TO CHANNEL 2, THE USER ENCOUNTERED SIGNIFICANT SCAR TISSUE AND PROBE PLACEMENT WAS DIFFICULT. THE PHYSICIAN REQUIRED THE USE OF TWO HANDS TO ADVANCE THE PROBE THROUGH THE SCAR TISSUE AND INTO THE TARGET LESION. THE CERTUS 140 WAS SET TO DELIVER 65W TO EACH PROBE. APPROXIMATELY 54 SECONDS INTO THE ENERGY DELIVERY, THE CERTUS 140 DETECTED A HIGH REFLECTED POWER ERROR ON THE PROBE IN CHANNEL 2. POWER DELIVERY TO CHANNEL 2 WAS AUTOMATICALLY STOPPED BY THE SYSTEM AND THE USER INTERFACE INDICATED THE ERROR CONDITION. THE USER INITIATED POWER DELIVERY TO THE PROBE IN CHANNEL 2 AGAIN. 7 SECONDS INTO THE ENERGY DELIVERY THE CERTUS 140 DETECTED A HIGH REFLECTED POWER ERROR ON THE PROBE IN CHANNEL 2. POWER DELIVERY TO CHANNEL 2 WAS AUTOMATICALLY STOPPED BY THE SYSTEM AND THE USER INTERFACE INDICATED THE ERROR CONDITION. THE USER INITIATED POWER DELIVERY TO THE PROBE IN CHANNEL 2 AGAIN. 1 SECOND INTO THE ENERGY DELIVERY, THE CERTUS 140 DETECTED A HIGH REFLECTED POWER ERROR ON THE PROBE IN CHANNEL 2. POWER DELIVERY TO CHANNEL 2 WAS AUTOMATICALLY STOPPED BY THE SYSTEM AND THE USER INTERFACED INDICATE THE ERROR CONDITION. THE USER MOVED THE PROBE TO CHANNEL 3. THE PROBE WAS TESTED AND FAILED DUE TO HIGH REFLECTED POWER. THE PROBE WAS RETESTED AND PASSED. THE USER INITIATED POWER DELIVERY TO THE PROBE IN CHANNEL 3. 1 SECOND INTO THE ENERGY DELIVERY, THE CERTUS 140 DETECTED A HIGH REFLECTED POWER ERROR ON THE PROBE IN CHANNEL 3. POWER DELIVERY TO CHANNEL 3 WAS AUTOMATICALLY STOPPED BY THE SYSTEM AND THE USER INTERFACE INDICATED THE ERROR CONDITION. A CT IMAGE WAS TAKEN AND INDICATED THAT THE PROBE TIP HAD BROKEN. THE BROKEN PROBE WAS REMOVED FROM PATIENT. A NEW CERTUS PR PROBE WAS USED AND THE CASE WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154943 CERTUS 140 2.45 GHZ ABLATION SYSTEM MICROWAVE ABLATION SYSTEM NEY NEUWAVE MEDICAL, INC PR ABLATION PROBE ML15111744

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other