BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTON CANNULATOME

    MDR report key: 3234021 · Received July 10, 2013

    Report

    Report Number
    3234021
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 10, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A COOK COTTON CANNULATOME WAS USED. THIS SPHINCTEROTOME WAS ADVANCED DOWN A FORWARD VIEWING PEDIATRIC COLONOSCOPE AND OVER A WIRE GUIDE. THE SPHINCTEROTOME HAD BEEN EXCHANGED IN AND OUT OF THE ENDOSCOPE SEVERAL TIMES BEFORE CURRENT WAS APPLIED. CURRENT WAS APPLIED TO PERFORM A SPHINCTEROTOMY, AND THE CUTTING WIRE BROKE OFF COMPLETELY. THE PRODUCT WAS WITHDRAWN AND ANOTHER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE CUTTING WIRE WAS NOT ABLE TO BE LOCATED AND IS STILL IN THE PT. THE DETACHED SECTION OF CUTTING WIRE WAS UNABLE TO BE LOCATED FOR RETRIEVAL AND REMAINED IN THE PT TO PASS NATURALLY THROUGH THE GASTROINTESTINAL TRACT. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317666 COTTON CANNULATOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. W3245540

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR ACTIVE CORD (UNKNOWN TYPE)| OLYMPUS PEDIATRIC DUODENOSCOPE (UNK MODEL NUMBER)| ERBE ELECTROSURGICAL UNIT