BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EB030, VOYANT FINE FUSION, 6/BX

    MDR report key: 6492353 · Received April 13, 2017

    Report

    Report Number
    2027111-2017-01712
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    March 10, 2017
    Report Date
    June 6, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    00607915127428
    PMA / PMN Number
    K153017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FOLLOW-UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT PRODUCT WAS NOT RETURNED FOR EVALUATION. BASED ON THE COMPLAINANT'S DESCRIPTION OF THE EVENT AND ADDITIONAL INFORMATION RECEIVED, IT COULD NOT BE DETERMINED IF A DEVICE MALFUNCTION OCCURRED. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. ALTHOUGH THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED, APPLIED MEDICAL IS CURRENTLY IMPLEMENTING CORRECTIVE ACTIONS WITHIN A CORRECTIVE AND PREVENTATIVE ACTION REPORT TO MITIGATE THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: THYROIDECTOMY USUAL TREATMENT: ASPEGIC 100 MG AND PREVISCAN (OBJECTIVE INR 2-3) THYROIDECTOMY FOR GOITRE BASED ON THE (B)(6) 2017. STOP OF PREVISCAN 5 DAYS BEFORE, RELAY LOVENOX 0.6 ML 2 / D. STOP THE LOVENOX THE DAY BEFORE THE INTERVENTION. RESUMPTION IN IMMEDIATE POST-OP. STOP ASPÉGIC STOPPED THE (B)(6), RESUMED AT D2. SURGICAL RECOVERY ON (B)(6) 2017 ORIGINAL: TRAITEMENT HABITUEL : ASPEGIC 100 MG ET PREVISCAN (OBJECTIF INR 2-3) THYROÏDECTOMIE POUR GOÎTRE BASEDOWIFIÉ LE (B)(6) 2017. ARRÊT DU PREVISCAN 5 JOURS AVANT, RELAIS LOVENOX 0.6 ML 2/J. STOP LE LOVENOX LA VEILLE DE L'INTERVENTION. REPRISE EN POST-OP IMMÉDIAT. ARRÊT ASPÉGIC STOPPÉ LE (B)(6), REPRIS À J2. REPRISE CHIRURGICALE LE (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED FROM CLINICAL AND SALES REP ON 12 APR 2017: BEFORE CONVERTING TO THE VOYANT FINE FUSION DEVICE THE SURGEONS WERE USING STANDARD BIPOLAR AND SOMETIMES CLIPS FOR THESE SURGERIES. THE ACCOUNT HAS BEEN USING VOYANT FINE FUSION DEVICE FOR ROUGHLY 3 MONTHS NOW. INITIAL EVENT DESCRIPTION COMMUNICATED BY THE SALES REP IS DESCRIBING THE RETURN OF THE PATIENT TO OPERATING ROOM AFTER DAY 5. COMPLAINT: BLEEDING 5 DAYS AFTER THE SURGERY. PATIENT STATUS- NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 19 APRIL 2017 : THE DEVICE FUNCTION NORMALLY DURING THE PROCEDURE. THERE WASN'T MORE BLEEDING THAN USUAL. THERE WAS NO ALARM TONE DURING ANY OF THE PROCEDURE. THERE WAS NOT CONDUCTIVE FLUID OR BLOOD POOLING AROUND THE JAWS BEFORE SEALING. THE NURSE USE TO CLEAN THE DEVICES AFTER ONE OR TWO FUSION CYCLES - NOT EXCESSIVE ESCHAR ON THE JAWS. THE PATIENT WAS ON ANTICOAGULANT. HE USES THE VOYANT SINCE A FEW MONTHS, SO HE MAKES A CONNECTION - IT'S DIFFICULT TO KNOW IF THE BLEEDING COMES FROM SPECIFICALLY FROM VESSELS SEALED WITH FINE FUSION ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 27 APRIL 2017 : THE SURGEON IS USED TO TAKE SCISSORS AND BIPOLAR IN ADDITION TO THE FINE FUSION VOYANT, FOR ALL THYROIDECTOMY. BEFORE USING FINE FUSION HE USED SOME CLIPS FOR THE BIGGEST VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270896 EB030, VOYANT FINE FUSION, 6/BX GEI GEI APPLIED MEDICAL RESOURCES EB030 1286728 00607915127428

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R