BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTUS 140 2.45 GHZ ABLATION SYSTEM

    MDR report key: 4667231 · Received April 7, 2015

    Report

    Report Number
    3008769756-2015-00001
    Event Type
    Injury
    Date Received
    April 7, 2015
    Date of Event
    March 10, 2015
    Report Date
    April 3, 2015
    Product Code
    GEI
    PMA / PMN Number
    K100744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PROBE MANUFACTURING RECORDS INDICATE THAT THE PROBE MET ALL SPECIFICATIONS. THE PROBE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION CONCLUDES THAT THE CERAMIC PORTION OF THE PROBE TIP, BETWEEN THE METAL TROCAR AND THE METAL SHAFT, WAS BROKEN. ADDITIONALLY, THE PROBE THERMOCOUPLE WIRES AND HEAT SHRINK HAD BEEN PUSHED BACK UP THE PROBE SHAFT. 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 1 20CM 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. CT IMAGING INDICATED THE PROBE NEEDED TO BE REPOSITIONED. THE PROBE WAS REMOVED AND THE INTRODUCER DRILL WAS USED TO OBTAIN DEEPER ACCESS TO THE TARGET. THE PROBE WAS REINSERTED THROUGH THE INTRODUCER AND INTO THE TARGET TISSUE. IMAGING CONFIRMED CORRECT PROBE POSITIONING. THE PROBE WAS REMOVED FROM THE INTRODUCER FOR THE REQUIRED PRE-ABLATION TESTING. AT THAT POINT THE PHYSICIAN NOTICED THE PROBE TIP WAS NOT INTACT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A SECOND CERTUS ABLATION PROBE WITHOUT FURTHER INCIDENT. POST-PROCEDURE CT IMAGING CONFIRMED THAT THE TIP OF THE FIRST PROBE REMAINED IN THE TARGET TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227557 CERTUS 140 2.45 GHZ ABLATION SYSTEM ELECTROSURGICAL CUTTING/COAGUALTION TOOL GEI PR ABLATION PROBE NM14050033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other