BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME STONE REMOVAL DEVICE

    MDR report key: 1051433 · Received May 21, 2008

    Report

    Report Number
    3005099803-2008-00514
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 23, 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED A BROKEN CUTTING WIRE, WHICH ALSO APPEARED CHARRED (FIGURE 1); THIS EXAM INDICATES THAT EXCESSIVE ELECTRICAL CURRENT FLOWED THROUGH THE DEVICE. ALTHOUGH THE CAUSE OF THE EXCESSIVE CURRENT IS UNKNOWN. POSSIBLE CAUSES INCLUDE: IMPROPER TOME POSITION ALLOWED THE CUTTING WIRE TO CONTACT THE ENDOSCOPE WHICH RESULTED IN A SHORT CIRCUIT AND EXCESSIVE POWER WAS APPLIED TO THE CUTTING WIRE DUE TO IMPROPER GENERATOR SETTINGS. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A REVIEW OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS FOR THIS LOT. THE 2008 15-MONTH STONETOME PRODUCT FAMILY COMPLAINT TREND REPORT. INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN ATTEMPTED TO COMPLETE THE SPHINCTEROTOMY PROCEDURE WITH THIS STONETOME STONE REMOVAL DEVICE. IT WAS REPORTED, HOWEVER, THAT THE DEVICE WAS UNABLE TO CUT AND THE PHYSICIAN "... FOUND THE CUTTING WIRE DETACHED." THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD STONETOME STONE REMOVAL DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ISSUE AND THE PT WAS REPORTED AS "GOOD" FOLLOWING THE PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2008-00513 FOR A DESCRIPTION OF THE FIRST EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME STONE REMOVAL DEVICE FDI BOSTON SCIENTIFIC CORPORATION M00535110 11356026

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK