BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 2141774 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02220
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE PRESENCE OF A WHITE CRYSTALLINE DEPOSIT (FOREIGN MATTER) ON THE BASE OF THE ARRAY AND THE CANNULA TIP. NO DAMAGE WAS VISIBLE TO THE PACKAGE OR PRODUCT. A PREVIOUS ANALYSIS WAS PERFORMED BY AN OUTSIDE LAB FOR AN ENERGY DISPERSIVE SPECTROSCOPY (EDS) MICROANALYSIS OF THE FOREIGN MATTER, WHICH IDENTIFIED THE ELEMENTS CONTAINED IN THE RESIDUE. THE ANALYSIS FOUND THAT THE MATERIAL CONTAINED SULFUR AND OXYGEN AS THE MAJOR ELEMENTS, WHILE CARBON, NITROGEN, AND PHOSPHOROUS WERE DETECTED AT LOWER LEVELS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT FOREIGN MATTER WAS IDENTIFIED AT THE TIP OF THE ELECTRODE. THE EVALUATION CONFIRMED THE PRESENCE OF THE FOREIGN MATTER AND PRIOR ANALYSIS OF THE MATERIAL FOUND THAT IT WAS OF NON-ORGANIC ORIGIN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE WAS BEING REMOVED FROM THE EXTERNAL PACKAGE FOR PLACEMENT IN THE WAREHOUSE. ACCORDING TO THE COMPLAINANT, AN ABNORMAL SUBSTANCE WAS IDENTIFIED AT THE ELECTRODE TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE WAS BEING REMOVED FROM THE EXTERNAL PACKAGE FOR PLACEMENT IN THE WAREHOUSE. ACCORDING TO THE COMPLAINANT, AN ABNORMAL SUBSTANCE WAS IDENTIFIED AT THE ELECTRODE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262160 12928254

    Patients

    Seq Age Sex Outcome Treatment
    1