BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOA POLYPECTOMY SNARE

    MDR report key: 3669996 · Received February 11, 2014

    Report

    Report Number
    3007591333-2014-00001
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 15, 2014
    Report Date
    February 11, 2014
    Manufacturer
    MICRO-TECH (NAN JING) CO., LTD.
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BOA POLYPECTOMY SNARE BROKE DURING A COLONOSCOPY PROCEDURE. THE LOOP CABLE BROKE AT THE POINT WHERE IT EXITS THE SHEATH. NO PATIENT INJURY RESULTED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER POLYPECTOMY SNARE. THE DEVICE WAS NOT RETAINED BY THE MEDICAL FACILITY AND WAS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89999 BOA POLYPECTOMY SNARE SNARE, FLEXIBLE FDI MICRO-TECH (NAN JING) CO., LTD. DSO-013 NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1