BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4243842 · Received November 11, 2014

    Report

    Report Number
    3005099803-2014-03639
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K110685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF FIBER BROKE. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED LASER FIBER REVEALED THAT THE EXPOSED GLASS TIP MEASURED 3.5 MM AND APPEARED UNUSED. THE LASER FIBER BODY WAS FRACTURED 14.0 CM FROM THE BOTTOM OF THE CONNECTOR AND THE BROKEN SECTION WAS STILL ATTACHED BY THE GREEN OUTER COATING. DAMAGE WAS CAUSED TO THE DEVICE WITHOUT DIRECT PATIENT CONTACT. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2014 THAT A FLEXIVA TRACTIP 200 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BODY OF THE LASER FIBER BROKE AFTER THE PHYSICIAN LAID A WET TOWEL ON IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2014 THAT A FLEXIVA TRACTIP 200 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BODY OF THE LASER FIBER BROKE AFTER THE PHYSICIAN LAID A WET TOWEL ON IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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
    725843 FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403960 ML00002409

    Patients

    Seq Age Sex Outcome Treatment
    1