BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER

    MDR report key: 6055341 · Received October 25, 2016

    Report

    Report Number
    3005099803-2016-03230
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    August 11, 2016
    Report Date
    September 29, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K082928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE ACCUMAX 1000 LASER FIBER WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION REVEALED THAT THE EXPOSED GLASS FIBER TIP MEASURED APPROXIMATELY 0.25 MM AND APPEARED USED. ADDITIONAL EXAMINATION UNDER MAGNIFICATION REVEALED THAT THE PATTERN ON THE TIP FACE WAS CONSISTENT WITH A FRACTURE INDICATING THAT THE TIP OR PORTION OF THE TIP BROKE OFF. THERE WAS NO DAMAGE OBSERVED ALONG THE FIBER BODY AND THE FIBER FACE WITHIN SUB MINIATURE-A (SMA) CONNECTOR. FUNCTIONAL ANALYSIS REVEALED THAT THE ¿ATTACH LASER FIBER¿ MESSAGE CLEARED THE CONSOLE AFTER ATTACHMENT INDICATING THAT THE FIBER WAS RECOGNIZED BY THE LASER UNIT. THE AIMING BEAM SEEN EXITING THE DISTAL TIP WAS BRIGHT, CLEAR AND SCATTERED WITH EFFECTIVE TRANSMISSION OF 83.5%. 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. 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

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2016-03229 AND 3005099803-2016-03230 FOR ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATIONS ON AUGUST 25, 2016 THAT TWO ACCUMAX 1000 LASER FIBERS WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST LASER FIBER (CAPTURED BY MNF REPORT #3005099803-2016-03229) WAS DEFECTIVE. THE PHYSICIAN ATTEMPTED TO USED A SECOND ACCUMAX LASER FIBER (CAPTURED BY MNF REPORT #3005099803-2016-03230) BUT THE FIBER WAS ALSO DEFECTIVE. NOTE: NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER TIP WAS DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704736 ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068404042 C000002877

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR