BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA010, VOYANT GENERATOR, 1/BX

    MDR report key: 8786175 · Received July 12, 2019

    Report

    Report Number
    2027111-2019-00510
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 14, 2019
    Report Date
    August 26, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    PMA / PMN Number
    K141288
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE EVENT UNIT, WHICH CONFIRMED THAT THE AUDIO LEVEL FROM THE UNIT WAS LOW DURING ACTIVATION. BASED ON THE EVALUATION OF THE RETURNED UNIT, THE LOW AUDIO LEVEL WAS CAUSED BY THE SPEAKER. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: HYSTERECTOMY LOW WAY COELIO PREPARED ORIGINAL: GÉNÉRATEUR ALLUMÉ, BRANCHEMENT DE LA PINCE (EB015, LOT 1353320) SUR LE PORT 2. L'ÉCRAN DU GÉNÉRATEUR S'EST ÉTEINT. J'AI ENLEVÉ LA PINCE, L'ÉCRAN EST RESTÉ NOIR. J'AI ÉTEINT ET RALLUMÉ LE GÉNÉRATEUR ET BRANCHÉ LA PINCE SUR LE PORT 1 ET CELA A FONCTIONNÉ. PENDANT L'INTERVENTION, LA PINCE A FONCTIONNÉ NORMALEMENT MAIS LE SON DU GÉNÉRATEUR ÉTAIT VRAIMENT TRÈS FAIBLE, À PEINE AUDIBLE, ALORS QUE LE VOLUME ÉTAIT RÉGLÉ AU MAXIMUM ET QUE RIEN N'OBSTRUAIT L'ENCEINTE. GENERATOR ON, CONNECTION OF THE DEVICE (EB015, LOT 1353320) ON PORT 2. THE GENERATOR SCREEN HAS GONE OUT. I REMOVED THE DEVICE, THE SCREEN REMAINED BLACK. I TURNED OFF AND TURNED ON THE GENERATOR AND PLUGGED THE DEVICE ON PORT 1 AND IT WORKED. DURING THE INTERVENTION, THE DEVICE WORKED NORMALLY BUT THE SOUND OF THE GENERATOR WAS REALLY WEAK, BARELY AUDIBLE, WHILE THE VOLUME WAS SET TO MAXIMUM AND NOTHING WAS BLOCKING THE SPEAKER. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS DID OCCUR ASSOCIATED WITH THE COMPLAINT EVENT. TYPE OF INTERVENTION: I TURNED OFF AND ON THE GENERATOR AND PLUGGED THE DEVICE ON PORT 1 AND IT WORKED.

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: HYSTERECTOMY LOW WAY COELIO PREPARED. GENERATOR ON, CONNECTION OF THE DEVICE (EB015, LOT 1353320) ON PORT 2. THE GENERATOR SCREEN HAS GONE OUT. I REMOVED THE DEVICE, THE SCREEN REMAINED BLACK. I TURNED OFF AND TURNED ON THE GENERATOR AND PLUGGED THE DEVICE ON PORT 1 AND IT WORKED. DURING THE INTERVENTION, THE DEVICE WORKED NORMALLY BUT THE SOUND OF THE GENERATOR WAS REALLY WEAK, BARELY AUDIBLE, WHILE THE VOLUME WAS SET TO MAXIMUM AND NOTHING WAS BLOCKING THE SPEAKER. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS DID OCCUR ASSOCIATED WITH THE COMPLAINT EVENT TYPE OF INTERVENTION: I TURNED OFF AND ON THE GENERATOR AND PLUGGED THE DEVICE ON PORT 1 AND IT WORKED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580188 EA010, VOYANT GENERATOR, 1/BX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES EA010 1350795

    Patients

    Seq Age Sex Outcome Treatment
    1 EB015| EB015