BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUFLEX

    MDR report key: 11228616 · Received January 26, 2021

    Report

    Report Number
    1000408433-2021-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    December 29, 2020
    Report Date
    January 26, 2021
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    MIJ
    UDI-DI
    04250195611574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUFLEX IS INTENDED AS A PREOPERATIVE MARKER OF NONPALPABLE SUSPECTED BREAST LESIONS TO FACILITATE THE INTRAOPERATIVE LOCALIZATION OF THE FINDINGS BY THE SURGEON. THE TUFLEX CONSISTS OF 19 TWISTED THIN WIRES WHICH GUARANTIES A HIGH FLEXIBILITY. DURING THE REMOVAL OF A SUSPECTED BREAST LESION THE SURGEON TOUCHED THE TUFLEX WIRE WITH THE ELECTRICAL CAUTERY DEVICE SEVERAL TIMES. THIS RESULTED IN A DAMAGE OF THE THIN WIRES AND SOME OF THEM BROKE. THE WHOLE SUSPECTED TISSUE HAS BEEN REMOVED BY THE SURGEON AND DURING THE FOLLOWING EXAMINATION OF THE TISSUE THE BROKEN WIRES HAVE BEEN DETECTED. NO SINGLE WIRE FRAGMENTS HAVE BEEN LEFT IN THE PATIENT. THE ENTIRE WIRE (INCLUDING FRAGMENTS) WERE REMOVED ALONG WITH THE SPECIMEN/LESION. NO ADDITIONAL SURGICAL INTERVENTION WAS NECESSARY. IN THIS CASE THE PATIENT WAS NOT DAMAGED. THE TUFLEX IS A NEW MARKING WIRE WITH A HIGH FLEXIBILITY DUE TO THE 19 TWISTED THIN WIRES. IN THE DEVELOPMENT PHASE OF THE PRODUCT THE POSSIBILITY OF CONTACT BETWEEN THE THIN WIRES AND THE ELECTRICAL CAUTER DEVICE HAS NOT BEEN CONSIDERED. CAUSED BY THE FACT THAT THIS INCIDENT COULD HAPPEN AGAIN WITH THE TUFLEX WIRE, SOMATEX DECIDED TO START A RECALL TO PREVENT PATIENTS FROM ANY HARM.

    Description of Event or Problem · 1

    DURING THE REMOVAL OF A SUSPECTED BREAST LESION THE MARKING WIRE TUFLEX WAS TAPPED WITH A CAUTERY DEVICE (BOVIE) AND IT SPLINTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130208 TUFLEX TUFLEX MIJ SOMATEX MEDICAL TECHNOLOGIES GMBH 271641 51269 04250195611574

    Patients

    Seq Age Sex Outcome Treatment
    1