BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-SEAL II

    MDR report key: 6191170 · Received December 20, 2016

    Report

    Report Number
    1722028-2016-00658
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 20, 2016
    Manufacturer
    TERUMO BCT EUROPE N.V.
    Product Code
    KSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. ADDITIONAL INVESTIGATION: TERUMO BCT LEUVEN INFORMED THE CUSTOMER WITH THE EVALUATION RESULTS OF THE RETURNED DEVICE. HOWEVER, THE CUSTOMER DECLINED REPAIR AND REQUESTED FOR THE DEVICE TO BE RETURNED TO THE CUSTOMER'S SITE. TERUMO BCT LEUVEN INITIATED AN INTERNAL CAPA FOR THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO TERUMO BCT (B)(4) FOR EVALUATION. UPON VISUAL INSPECTION, WEAR WAS NOTED ON THE MOVING ELECTRODE WITH MISSING PLATING. DAMAGE WAS ALSO OBSERVED ON THE SEALING RIM AND BLOOD WAS NOTED ON BOTH THE FIXED AND MOVING ELECTRODES. IT WAS ALSO NOTED THAT THE DEVICE HAD BURN MARKS ORIGINATING FROM THE OUTSIDE OF THE DEVICE. THERE WAS NO INDICATION OF BURNS ON THE INSIDE OF THE DEVICE. TWENTY WELDS WERE PERFORMED WITH THE DEVICE AND THE SEALS WERE NORMAL. THE DEVICE IS FUNCTIONING CORRECTLY. THE MANUFACTURING RECORDS WERE REVIEWED. NO ABNORMALITIES WERE NOTED IN THE RECORDS THAT WOULD HAVE CONTRIBUTED TO THE ISSUE. ROOT CAUSE: THE ROOT CAUSE OF THIS FAILURE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT (OPERATOR) INFORMATION AND OUTCOME ARE NOT AVAILABLE FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE SEALING TUBING, THERE WAS A "FLAME" COMING FROM THE BOTTOM OF THE SEALER DEVICE. THE DEVICE HAS BEEN TAKEN OUT OF USE. NO PATIENT OR DONOR WAS PRESENT OR CONNECTED AT THE TIME OF THE EVENT, AND THE CONDITION OF THE OPERATOR OF THE DEVICE IS NOT KNOWN AT THIS TIME. THE PATIENT (OPERATOR) INFORMATION IS NOT AVAILABLE AT THIS TIME. TERUMO BCT (B)(4) IS AWAITING RETURN OF THE DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841737 T-SEAL II ME-TSEAL2 TUBE SEALING DEVICE 100-240V KSD TERUMO BCT EUROPE N.V. 2METSEAL2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other