BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 4079801 · Received September 11, 2014

    Report

    Report Number
    3005099803-2014-03053
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED LASER FIBER REVEALED THAT THE EXPOSED GLASS TIP MEASURED 3.5 MM AND APPEARED USED. THE INVESTIGATOR WAS UNABLE TO EXAMINE THE FIBER FACE WITHIN THE SUB MINIATURE-A (SMA) CONNECTOR BECAUSE LIGHT WAS UNABLE TO TRAVEL TO THE FIBER FACE. THIS INDICATED THAT THE FIBER IS BROKEN WITHIN THE CONNECTOR. GIVEN THE EVENT DESCRIPTION AND CONDITION OF THE RETURNED DEVICE, THERE ISN'T ENOUGH INFORMATION TO DETERMINE A PROBABLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF FIBER CONNECTOR OVERHEATS. (B)(4) FOR THE REPORTED EVENT OF BURN TO THE NURSE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIVA 1000 LASER FIBER WAS USED DURING A LITHOTRIPSY FOR BLADDER STONE PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2014. THE SETTINGS FOR THE LASER UNIT WERE 2J X 50HZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER 30 MINUTES OF USING THE LASER FIBER A BURNING SMELL WAS NOTED BUT THERE WAS NO LOSS OF LASER ENERGY NOTED AND THE PHYSICIAN CONTINUED THE PROCEDURE. AFTER AN ADDITIONAL 15 MINUTES, THE FIBER POWER OUTPUT DRAMATICALLY REDUCED AND THE LASER FIBER CONNECTOR OVERHEATED. THE NURSE ATTEMPTED TO REMOVE THE LASER FIBER FROM THE GENERATOR AND SUSTAINED A SLIGHT BURN OF THE RIGHT INDEX FINGER AND THUMB. THE BURN WAS TREATED WITH COLD WATER AND A DRY DRESSING WAS APPLIED, NOT REQUIRING ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH A FLEXIVA 550 LASER FIBER USING THE SAME LASER UNIT SET AT 2J X 25HZ. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIVA 1000 LASER FIBER WAS USED DURING A LITHOTRIPSY FOR BLADDER STONE PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2014. THE SETTINGS FOR THE LASER UNIT WERE 2J X 50HZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER 30 MINUTES OF USING THE LASER FIBER A BURNING SMELL WAS NOTED BUT THERE WAS NO LOSS OF LASER ENERGY NOTED AND THE PHYSICIAN CONTINUED THE PROCEDURE. AFTER AN ADDITIONAL 15 MINUTES, THE FIBER POWER OUTPUT DRAMATICALLY REDUCED AND THE LASER FIBER CONNECTOR OVERHEATED. THE NURSE ATTEMPTED TO REMOVE THE LASER FIBER FROM THE GENERATOR AND SUSTAINED A SLIGHT BURN OF THE RIGHT INDEX FINGER AND THUMB. THE BURN WAS TREATED WITH COLD WATER AND A DRY DRESSING WAS APPLIED, NOT REQUIRING ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH A FLEXIVA 550 LASER FIBER USING THE SAME LASER UNIT SET AT 2J X 25HZ. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562069 FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403941 ML00001516

    Patients

    Seq Age Sex Outcome Treatment
    1 Other