BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILSON-COOK MEDICAL

    MDR report key: 320344 · Received March 13, 2001

    Report

    Report Number
    320344
    Event Type
    Malfunction
    Date Received
    March 13, 2001
    Date of Event
    March 9, 2001
    Report Date
    March 9, 2001
    Manufacturer
    WILSON-COOK MEDICAL
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOUND POLYP. DR USED MINI SNARE TO RETRIEVE THE POLYP. PUT WIRE AROUND THE POLYP. APPLIED LIGHT PRESSURE. DR PUSHED PEDAL FOR CAUTERIZING. GENTLE PRESSURE TO SNARE TO RETRIEVE POLYP. DR PULLED OUT THE SNARE. TAG WIRE LOOP WAS LEFT IN PT. WIRE LOOP BROKE OFF. POLYP ABOUT 3/4 WAY OFF. HAD TO RETRIEVE WIRE IMMEDIATELY WITH FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11216 WILSON-COOK MEDICAL ACUSNARE POLYPECTOMY SNARE FDI WILSON-COOK MEDICAL ASM 1-S 1426842

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other