BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2844665 · Received November 26, 2012

    Report

    Report Number
    3005099803-2012-05260
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K110685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT USED PAST EXPIRY DATE.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER ON (B)(6) 2013: THE BLACKENED JACKET WAS AT THE TIP OF THE FIBER DUE TO NORMAL FIBER DEGRADATION AND FUNCTION. THE CUSTOMER ALSO CLARIFIED THAT THE ORIGINALLY REPORTED COMPLAINT WAS REPORTED IN ERROR DUE TO A COMMUNICATION MISUNDERSTANDING. THERE WAS NO FAILURE OF THE DEVICE AND NO COMPLAINT REPORTED ON THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT WITHIN THE FIRST 5 MINUTES OF A URETEROSCOPY PROCEDURE USING A FLEXIVA 200 TRACTIP LASER FIBER, THE BALL TIP OF THE FIBER DEGRADED AT .16 KILOJOULES. WHEN THE ENERGY WAS INCREASED TO .77 KILOJOULES, THE TIP OF THE FIBER; LESS THE BALL WAS PRESENT. HOWEVER, THE JACKET OF THE FIBER WAS BLACKENED APPROXIMATELY 4MM. THE FIBER DID NOT APPEAR TO BE OVERHEATED. THE FIBER WAS POSITIONED 1 MM IN DISTANCE FROM THE KIDNEY STONE. LASER ENERGY FROM A LUMENIS 100 WATT LASER WAS BEING USED WITH THE FIBER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITHOUT ANY COMPLICATIONS TO THE PATIENT WHO IS REPORTEDLY 'FINE' POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT WITHIN THE FIRST 5 MINUTES OF A URETEROSCOPY PROCEDURE USING A FLEXIVA 200 TRACTIP LASER FIBER, THE BALL TIP OF THE FIBER DEGRADED AT .16 KILOJOULES. WHEN THE ENERGY WAS INCREASED TO .77 KILOJOULES, THE TIP OF THE FIBER; LESS THE BALL WAS PRESENT. HOWEVER, THE JACKET OF THE FIBER WAS BLACKENED APPROXIMATELY 4MM. THE FIBER DID NOT APPEAR TO BE OVERHEATED. THE FIBER WAS POSITIONED 1 MM IN DISTANCE FROM THE KIDNEY STONE. LASER ENERGY FROM A LUMENIS 100 WATT LASER WAS BEING USED WITH THE FIBER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITHOUT ANY COMPLICATIONS TO THE PATIENT WHO IS REPORTEDLY "FINE" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403960

    Patients

    Seq Age Sex Outcome Treatment
    1 LUMENIS 100 WATT LASER