BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 6156234 · Received December 8, 2016

    Report

    Report Number
    3005099803-2016-03782
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 18, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K110685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFG SITE NAME- COHERENT INC. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2016-03718 AND 3005099803-2016-03782 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 18, 2016 THAT TWO FLEXIVA 200 TRACTIP LASER FIBER WERE USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2016. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 120W WITH LASER SETTINGS OF 0.3 J AND 70 HZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE FIRST LASER FIBER WAS WORKING BRIEFLY AT THE BEGINNING OF THE CASE THEN THE AIMING BEAM SUDDENLY WENT OFF AND LASER ENERGY STOPPED FIRING. THE CONNECTOR WAS REMOVED FROM THE LASER UNIT AND IT WAS EXTREMELY HOT TO TOUCH. THE SAME ISSUE OCCURRED WITH THE SECOND FLEXIVA LASER FIBER. THERE WAS NO BURN INJURY TO THE NURSE AND NO INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA 200 TRACTIP LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805474 FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403961 C000003780

    Patients

    Seq Age Sex Outcome Treatment
    1