BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 4769385 · Received May 13, 2015

    Report

    Report Number
    3005099803-2015-01264
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    February 13, 2015
    Report Date
    April 22, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFG SITE NAME-COHERENT INC. ONE FLEXIVA 200 LASER FIBER WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED LASER FIBER REVEALED THAT THE EXPOSED GLASS TIP MEASURED 3.5MM AND APPEARED UNUSED. 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, INDICATING THAT THE FIBER IS BROKEN WITHIN THE CONNECTOR. FUNCTIONAL ANALYSIS REVEALED THAT THE ¿ATTACH LASER FIBER¿ MESSAGE CLEARED FROM THE CONSOLE AFTER ATTACHMENT INDICATING THAT THE FIBER WAS RECOGNIZED BY THE LASER UNIT. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE COMPLAINT OF ¿LASER FIBER INCORRECTLY ATTACHED TO LASER UNIT¿ WAS NOT CONFIRMED. HOWEVER, THE MOST PROBABLE ROOT CAUSE FOR THE LASER FIBER BROKEN WITHIN THE CONNECTOR IS HANDLING DAMAGE. THE ISSUE WAS FIRST NOTICED DURING PREPARATION AND OCCURRED OUTSIDE THE PATIENT, AND A FIBER BROKEN WITHIN THE CONNECTOR WOULD ALSO RESULT IN NO LASER ENERGY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 20, 2015 THAT A FLEXIVA 200 LASER FIBER WAS USED DURING A CYSTOSCOPY LASER LITHOTRIPSY PERFORMED ON (B)(6) 2015. THE LASER UNIT WAS A LUMENIS HOLMIUM LASER. ACCORDING TO THE COMPLAINANT, OUTSIDE OF THE PATIENT DURING THE PREPARATION, THE LASER FIBER WOULD NOT ACTIVATE AND THERE WERE NO PULSES. THE TECHNICIAN TRIED TO UNPLUG THE FIBER AND THEN PUT THE FIBER BACK ON THE LASER UNIT BUT THE LASER UNIT WOULD NOT RECOGNIZE THE FLEXIVA LASER FIBER. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311812 FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403910 C000001515

    Patients

    Seq Age Sex Outcome Treatment
    1