BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME STONE REMOVAL DEVICE

    MDR report key: 1022180 · Received March 26, 2008

    Report

    Report Number
    3005099803-2008-00303
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE EVALUATION IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT REVEALED NO ANOMALIES. THE FEBRUARY 2008 15-MONTH STONETOME SPHINCTEROTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO THE SECOND OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2008-00302 FOR A DESCRIPTION OF THE FIRST EVENT. ACCORDING TO THE COMPLAINANT, "... A SECOND STONETOME WAS USED TO CUT THE PAPILLA AT 120W. THE PHYSICIAN TURNED ON THE ELECTRICITY TO 40W FOR HEMOSTASIS. AFTER ACTIVATING THE SPHINCTEROTOME 5 OR 6 TIMES ... THE CUTTING WIRE DETACHED." THE PROCEDURE WAS COMPLETED WITH A THIRD STONETOME STONE REMOVAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ISSUE AND THE PATIENT'S CONDITION WAS REPORTED AS "GOOD" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME STONE REMOVAL DEVICE FDI BOSTON SCIENTIFIC CORPORATION M00535190 11314541

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK