BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYPECTOMY SNARE

    MDR report key: 1340214 · Received March 5, 2009

    Report

    Report Number
    3005099803-2009-01049
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Report Date
    February 6, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODE: NO PT CODES LISTED AS THE PT WAS NOT INVOLVED IN THE EVENT. THE DEVICE HAS BEEN RECEIVED BY THIS MFR, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF THE EVENT AND PROCEDURE DATE ARE UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON 02/06/2009, THAT A POLYPECTOMY SNARE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THEY WERE APPLYING CAUTERY TO THE PT AND THE NURSE FELT AN ELECTRICAL SURGE ON HER HAND FROM THE DEVICE. THE NURSE REQUIRED NO TREATMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLYPECTOMY SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYPECTOMY SNARE FDI BOSTON SCIENTIFIC CORPORATION M00560321 11878545

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK