BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER

    MDR report key: 5830221 · Received July 28, 2016

    Report

    Report Number
    3005099803-2016-02155
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Report Date
    July 7, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K093691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN.  IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4). ONE ACCUTRAC 200 LASER FIBER WAS RECEIVED FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE EXPOSED GLASS TIP MEASURES 3.0 MM AND APPEARED USED. EXAMINATION UNDER MAGNIFICATION REVEALED THAT THE TIP FACE WAS CONSISTENT WITH NORMAL DEGRADATION. THERE WAS NO DAMAGE NOTED ALONG THE BODY OF THE FIBER. 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 WAS 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. AS A RESULT, NO AIMING BEAM WAS VISIBLE AND EFFECTIVE TRANSMISSION WAS NOT MEASURED. THE CONDITION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. THE NOTED DAMAGES INDICATE DIFFICULTY WAS EXPERIENCED DURING THE PROCEDURE AND ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2016 THAT AN ACCUMAX 200 LASER FIBER WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE LASER UNIT USED WAS DORNIER MEDILAS H20 WITH SETTINGS OF 8 HZ X 1500 MJ AND 12 WATTS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LASER FIBER SUDDENLY STOPPED FIRING LASER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY. 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
    481115 ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068404012

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR