BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 2153297 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02084
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K992477
    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 REVEALED NO ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE ELECTRICAL FAILURE. ELECTRICAL TESTING WAS PERFORMED BY CONNECTING THE LEADS OF A DIGITAL MULTIMETER TO THE CAUTERY PLUG, AS WELL AS TO THE DISTAL LOOP. THE RESISTANCE BETWEEN THE LEADS WAS WITHIN SPEC. THE INVESTIGATION REVEALED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. COMPLAINT NOT CONFIRMED. A REVIEW OF THE REPORTED LOT WAS PERFORMED; NO SIMILAR REPORTS HAVE BEEN RECEIVED. THE (B)(6) 2008, 15-MONTH ROTATABLE SNARE PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON (B)(6) 2008 THAT A ROTATABLE SNARE DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THERE WAS INSUFFICIENT ELECTRICAL CURRENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATABLE SNARE FDI BOSTON SCIENTIFIC CORPORATION M00561831 11314357

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK