BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTUS 140 2.45 GHZ ABLATION SYSTEM

    MDR report key: 5365601 · Received January 13, 2016

    Report

    Report Number
    3008769756-2016-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Date of Event
    December 16, 2015
    Report Date
    January 13, 2016
    Manufacturer
    NEUWAVE MEDICAL, INC
    Product Code
    NEY
    PMA / PMN Number
    K113237
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBES HAVE NOT YET BEEN RETURNED FOR EVALUATION. NEUWAVE IS ACTIVELY ATTEMPTING TO OBTAIN THE PROBES FROM THE CUSTOMER. SYSTEM LOGS WERE REVIEWED AND THEY CONFIRMED THE EVENTS REPORTED BY THE USER. A REVIEW OF THE PROBE LOT HISTORY RECORDS INDICATE THAT BOTH PROBES PASSED ALL MFG SPECIFICATIONS AND NO ANOMALIES WERE NOTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE PROBES ARE RETURNED AND AN INVESTIGATION CAN BE COMPLETED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING TWO CERTUSPR PROBES TO ABLATE A RENAL LESION IN A PATIENT OF UNKNOWN AGE AND GENDER. THE PROBES WERE VERY CLOSE TOGETHER SUCH THAT THEY WERE "PRETTY MUCH ON TOP OF ONE ANOTHER AFTER THE TISSUE CONTRACTED". THE PHYSICIAN STARTED ABLATING WITH BOTH PROBES AND THE TEMPS WERE "FAIRLY HIGH (>160 C ON AT LEAST ONE OF THEM)". ONE PROBE GAVE AN ERROR WITHIN APPROXIMATELY 2 MINUTES OF STARTING THE ABLATION. THE OTHER PROBE GENERATED AN ERROR AFTER 4.5 MIN. BOTH PROBES GAVE "TEMP TOO HIGH" ERRORS. MULTIPLE ATTEMPTS WERE MADE TO RETEST THE PROBES AND CONTINUE THE PROCEDURE. SYSTEM WAS REBOOTED BUT ERRORS PERSISTED. BOTH PROBES WERE EVENTUALLY REMOVED. THE TIPS OF BOTH PROBES WERE RETAINED IN THE LESION. PHYSICIAN REPORTED THAT NO EXCESSIVE FORCE WAS USED ON THE PROBES. PROBES WILL BE RETURNED TO THE MANUFACTURER. THE CASE WAS COMPLETED WITH ANOTHER PR PROBE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23998 CERTUS 140 2.45 GHZ ABLATION SYSTEM MICROWAVE ABLATION SYSTEM NEY NEUWAVE MEDICAL, INC PR ABLATION PROBE NM15110014 AND NM15110010

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other