BEUDAMED
    FDA Adverse Event Other Summary report: N

    VOCAL FOLD INFUSION NEEDLE

    MDR report key: 952063 · Received November 21, 2007

    Report

    Report Number
    1225968-2007-00001
    Event Type
    Other
    Date Received
    November 21, 2007
    Date of Event
    October 19, 2007
    Report Date
    November 20, 2007
    Manufacturer
    ENDOCRAFT LLC.
    Product Code
    KAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 'VOCAL FOLD INFUSION NEEDLE' WAS DESIGNED TO BE USED SOLELY FOR THE VOCAL FOLD THROUGH A DIRECT LARYNGOSCOPE AND WITH MAGNIFICATION PROVIDED BY A SURGICAL MICROSCOPE. FOR A NUMBER OF REASONS, IT IS NOT SAFE TO USE AN ANGLED LARYNGEAL NEEDLE IN OTHER SITES SUCH AS THE ESOPHAGUS, WHICH IS EXACTLY WHAT WAS DONE IN THIS CASE. AS YOU WILL NOTE IN THE DIAGRAMS IN THE INSTRUCTIONS-FOR-USE THAT ACCOMPANIED THE NEEDLES, ONLY THE DISTAL ANGLED 3MM TIP OF THE NEEDLE SHOULD HAVE BEEN PENETRATING THE TISSUE SO THAT ANY FORCE-RELATED BENDING SHOULD HAVE BEEN OBVIOUS WHILE VIEWING THROUGH THE SURGICAL MICROSCOPE. THEREFORE, THE SURGEON SHOULD HAVE SEEN THE NEEDLE IF IT WAS BENDING OR BREAKING. FURTHERMORE, EVEN IF THE EXCESSIVE FORCE-RELATED BENDING WAS MISSED AND THE NEEDLE FRACTURED FROM THE SHAFT, IT SHOULD HAVE BEEN SIMPLE TO REMOVE THE NEEDLE. SINCE ONLY THE DISTAL ANGLED ASPECT OF THE NEEDLE SHOULD HAVE BEEN IN THE SOFT TISSUE, THE PROXIMAL ASPECT OF THE NEEDLE WOULD HAVE BEEN EASILY SEEN EMANATING FROM THE SURGEON'S PUNCTURE SITE. THE OPERATING NURSE EXPLAINED THAT SHE WAS SURPRISED AT THEIR CURRENT SCENARIO EXPLAINING THAT NO ONE AT THEIR INSTITUTION HAD PRIOR DIFFICULTIES WITH THE VOCAL FOLD INFUSION NEEDLES. IN FACT, THIS IS THE FIRST INDICATION OF A PROBLEM THAT ENDOCRAFT HAS HEARD ABOUT.

    Description of Event or Problem · 1

    THE OPERATING NURSE CONTACTED US AND INDICATED THAT DR HAD BROKEN A VOCAL FOLD INFUSION NEEDLES FROM ITS SHAFT WHILE USING IT TO INJECT THE ESOPHAGUS OF A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOCAL FOLD INFUSION NEEDLE LARYNGEAL INJECTING DEVICE KAA ENDOCRAFT LLC. UMG 100A 110205

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention