BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 2140948 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02161
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED FIBER REVEALED APPROXIMATELY 3.5 MM OF THE FIBER TIP WAS MISSING. THE REMAINING EXPOSED TIP MEASURED 0.5 MM AND THE PATTERN ON THE TIP FACE WAS CONSISTENT WITH A FRACTURE. HANDLING DAMAGE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE (B)(4) AND (B)(4) RELATES TO THE REPORTED EVENT OF FIBER BENT OR BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR A URETEROSCOPY PROCEDURE, THE NURSE OPENED THE PACKAGE OF THE FLEXIVA 365 LASER FIBER (BOX 5) AND OBSERVED THAT THE FIBER WAS BENT OR BROKEN; BUT COULD NOT CONFIRM WHICH. THE NURSE DID CONFIRM THAT THE PACKAGE DID NOT APPEAR TO BE DAMAGED DURING SHIPPING OR HANDLING AND WAS INTACT, WITHOUT SIGNS OF TAMPERING. THE PHYSICIAN DID NOT ATTEMPT TO STRAIGHTEN THE FIBER, AS HE OPINED THAT THE FLEXIVA 365 FIBER WAS UNUSABLE WHEN HE FIRST EXAMINED IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 365 LASER FIBER WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR A URETEROSCOPY PROCEDURE, THE NURSE OPENED THE PACKAGE OF THE FLEXIVA 365 LASER FIBER (BOX 5) AND OBSERVED THAT THE FIBER WAS BENT OR BROKEN; BUT COULD NOT CONFIRM WHICH. THE NURSE DID CONFIRM THAT THE PACKAGE DID NOT APPEAR TO BE DAMAGED DURING SHIPPING OR HANDLING AND WAS INTACT, WITHOUT SIGNS OF TAMPERING. THE PHYSICIAN DID NOT ATTEMPT TO STRAIGHTEN THE FIBER, AS HE OPINED THAT THE FLEXIVA 365 FIBER WAS UNUSABLE WHEN HE FIRST EXAMINED IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 365 LASER FIBER WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403921 1ML1022207

    Patients

    Seq Age Sex Outcome Treatment
    1