BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER

    MDR report key: 4190406 · Received October 21, 2014

    Report

    Report Number
    3005099803-2014-03434
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K082928
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FIBER BROKE. (B)(4) FIBER MISFIRED. (B)(4) MINOR BURN TO THE PHYSICIAN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-03448 AND 3005099803-2014-03434 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2014 THAT TWO ACCUMAX 200 LASER FIBERS WERE USED DURING A CYSTOSCOPY URETERAL STONE WITH LASER PROCEDURE IN THE URETER AND KIDNEY PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, THE TIP OF THE FIRST LASER FIBER BROKE (THE SUBJECT OF MFR. REPORT #3005099803-2014-03448). A SECOND ACCUMAX LASER FIBER (THE SUBJECT OF MFR. REPORT #3005099803-2014-03434) WAS USED AND THE FIBER BROKE WHEN LASER ENERGY WAS FIRED, CAUSING A MINOR BURN TO THE PHYSICIAN'S HAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667504 ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068404012 C000001210

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other