BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOA POLYPECTOMY SNARE

    MDR report key: 4254625 · Received November 4, 2014

    Report

    Report Number
    3007591333-2014-00009
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    June 25, 2013
    Report Date
    October 30, 2014
    Manufacturer
    MICRO-TECH (NAN JING) CO., LTD.
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BOA POLYPECTOMY SNARE WAS BEING USED DURING A COLONOSCOPY TO RESECT A LARGE PEDUNCULATED POLYP. WHEN THE OPERATOR TRIED TO INITIATE THE ELECTROCAUTERY, THE SNARE FAILED TO COAGULATE. THE SNARE WAS THEN REMOVED FROM THE COLONOSCOPE AND TESTED, AND IT WAS DETERMINED THAT THE SNARE FAILED TO DELIVER ENERGY WHEN ELECTROCAUTERY WAS APPLIED. THE INFORMATION ORIGINATES FROM THE SALES REPRESENTATIVE WHO WAS AT THE SITE DURING THE CASE. THE CASE WAS COMPLETED USING ANOTHER INSTRUMENT. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THIS REPORT FOLLOWS FROM A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS BY THE SUBMITTER AFTER REVISION OF REPORTING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706680 BOA POLYPECTOMY SNARE SNARE, FLEXIBLE FDI MICRO-TECH (NAN JING) CO., LTD. DSO-013 130303301

    Patients

    Seq Age Sex Outcome Treatment
    1