BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCLEROTHERAPY NEEDLE

    MDR report key: 6636219 · Received June 13, 2017

    Report

    Report Number
    6636219
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    June 7, 2017
    Report Date
    June 12, 2017
    Manufacturer
    TELEMED SYSTEMS INC.
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE REPORTED THAT DURING THIS PROCEDURE, THE NURSE INTRODUCED A SCLEROTHERAPY NEEDLE TO THE FIELD; WHEN IT WAS BEING ADVANCED DOWN THE ENDOSCOPE, THE PHYSICIAN NOTICED THAT THE COVERING HAD BECOME PARTIALLY REMOVED EXPOSING THE INNER METAL DEVICE. THIS PRODUCT WAS WITHDRAWN AND A NEW DEVICE USED. THE AREA OF CONCERN DID NOT REACH THE PATIENT AND THE ENDOSCOPE WAS NOT HARMED. THE DEVICE WAS SAVED AND WILL BE RELEASED TO THE COMPANY REPRESENTATIVE ON WEDNESDAY. (FOR THE CONVENIENCE OF THE COMPANY'S REVIEW) PICTURES WILL BE SENT SEPARATE FROM THIS REPORT TO THE FDA. MANUFACTURER RESPONSE FOR SCLEROTHERAPY NEEDLE, SCLEROTHERAPY NEEDLE 25GA X 5MM (PER SITE REPORTER): I WILL INCLUDE THE REPS NAME PRIOR TO CLOSING THIS EVENT FOR FINAL SUBMISSION. THE DEVICE IS DISPOSABLE. THE DEVICE AND PACKAGE WILL BE RELEASED TO COMPANY REP THE COMPANY IS TELEMED. I PUT THE PACKAGE PIC AND THE LOT # AND EXP DATE INTO THE SR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418442 SCLEROTHERAPY NEEDLE ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK TELEMED SYSTEMS INC. L16702040

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR A COLONOSCOPE