BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA010, VOYANT ESG 1/BX

    MDR report key: 6266590 · Received January 20, 2017

    Report

    Report Number
    2027111-2017-00044
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Report Date
    March 21, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    10607915131378
    PMA / PMN Number
    K141288
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE ELECTROSURGICAL GENERATOR (ESG) WAS RETURNED FOR EVALUATION. UPON FUNCTIONAL TESTING, ENGINEERING PERFORMED AN ESG OUTPUT VERIFICATION TEST AND CONFIRMED THAT THE ESG IS CAPABLE OF DELIVERING CONTROLLED ENERGY FOR SEAL FUNCTION. AS SUCH, ENGINEERING WAS UNABLE TO REPLICATE THE EVENT AND DETERMINED THAT THE ESG FUNCTIONED AS INTENDED. ALTHOUGH THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED, APPLIED MEDICAL WILL MONITOR ITS VIGILANCE SYSTEMS FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. THIS REPORT, INCIDENT (B)(4), MEDWATCH NO: 2027111-2017-00044, IS RELATED TO TWO HAND-PIECE DEVICE REPORTS: INCIDENT (B)(4), MEDWATCH NO: 2027111-2017-00037 AND INCIDENT (B)(4), MEDWATCH NO: 2027111-2017-00038. REFER TO THE HAND-PIECE DEVICE REPORTS FOR THEIR RESPECTIVE INVESTIGATION SUMMARIES.

    Description of Event or Problem · 1

    ESOPHAGUS - "OF THE LAST TWO INTERVENTIONS HE PERFORMED WITH THE VOYANT, HE FOUND A LESS GOOD HEMOSTASIS THAN USUAL. HE WAS OBLIGED TO REPEAT REGULARLY THESE HAEMOSTASES WHICH BLEED SYSTEMATICALLY WHILE THE GENERATOR INDICATED A NORMAL FUSION CYCLE. HE FIRST THOUGHT OF A PROBLEM ON THE HAND PIECE, WHICH HE CHANGED, BUT HE FOUND THAT THE PROBLEM DID NOT GO AWAY. WORKING ON SEVERAL ROOMS WITH DIFFERENT GENERATORS, HE REALIZED THAT THE PROBLEM HAD ONLY OCCURRED WITH THE SAME GENERATOR. HE WANTS US TO CHECK IT. I'LL GET IT BACK THIS MORNING." ORIGINAL: DETAILED DESCRIPTION OF EVENT: SUR LES DEUX DERNIÈRES INTERVENTIONS QU'IL A RÉALISÉ AVEC LE VOYANT, IL A CONSTATÉ UNE MOINS BONNE HÉMOSTASE QUE D'HABITUDE. IL ÉTAIT OBLIGÉ DE REPRENDRE RÉGULIÈREMENT CES HÉMOSTASES QUI SAIGNAIENT SYSTÉMATIQUEMENT ALORS QUE LE GÉNÉRATEUR INDIQUAIT UN CYCLE DE FUSION NORMAL. IL A D'ABORD PENSÉ À UN PROBLÈME SUR LA PINCE, QU'IL A FAIT CHANGER, MAIS IL A CONSTATÉ QUE LE PROBLÈME NE DISPARAISSAIT PAS. TRAVAILLANT SUR PLUSIEURS SALLES AVEC DES GÉNÉRATEURS DIFFÉRENTS, IL S'EST APERÇU QUE LE PROBLÈME S'ÉTAIT PRODUIT UNIQUEMENT AVEC LE MÊME GÉNÉRATEUR. IL SOUHAITE QUE NOUS FASSIONS UN CONTRÔLE DE CELUI-CI.JE PASSE LE RÉCUPÉRER CE MATIN. PATIENT STATUS: GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50678 EA010, VOYANT ESG 1/BX GEI GEI APPLIED MEDICAL RESOURCES EA010 1260464 10607915131378

    Patients

    Seq Age Sex Outcome Treatment
    1 EB010