BEUDAMED
    FDA Adverse Event Other Summary report: N

    TELEMED MICRO CRESCENT SNARE

    MDR report key: 236446 · Received August 6, 1999

    Report

    Report Number
    1222168-1999-00001
    Event Type
    Other
    Date Received
    August 6, 1999
    Date of Event
    July 28, 1999
    Report Date
    August 4, 1999
    Manufacturer
    TELEMED SYSTEMS, INC.
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE COLONOSCOPY, THE SNARE DEVICE WAS PLACED IN A PENTAX COLONOSCOPE (MODEL EC-3801L). THE DEVICE BECAME LODGED IN THE SCOPE AND COULD NOT BE ADVANCED. THE DEVICE WAS WITHDRAWN AND A SECOND SNARE WAS PLACED. THE 2ND SNARE WOULD NOT ADVANCE. A HOT BIOPSY FORCEPS WAS THEN INSERTED AND PUSHED THROUGH THE AREA OF DIFFICULTY. THE METAL SLEEVE FROM THE FIRST SNARE EXITED THE SCOPE INTO THE COLON. THE SLEEVE WAS NOT RETRIEVED, BUT THE 2ND SNARE WAS REINSERTED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEMED MICRO CRESCENT SNARE SNARE (ENDOSCOPIC ACCESSORY) FDI TELEMED SYSTEMS, INC. 4014 B11994014

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR