BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA010, VOYANT ESG 1/BX

    MDR report key: 6380387 · Received March 6, 2017

    Report

    Report Number
    2027111-2017-01308
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    March 12, 2015
    Report Date
    March 3, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED FOR INVESTIGATION. ENGINEERING WAS ABLE TO CONFIRM THE CUSTOMER'S EXPERIENCE. UPON FURTHER INSPECTION, ENGINEERING FOUND INTERNAL DAMAGE. THE ROOT CAUSE OF THE CUSTOMER EXPERIENCE IS THE INTERNAL DAMAGE CAUSED DURING SHIPPING. APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE DEVICE ENHANCEMENTS INTENDED TO MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. THIS REPORT IS BEING FILED AS A RESULT OF A RE-REVIEW OF APPLIED MEDICAL COMPLAINTS RECEIVED BETWEEN JUNE 1, 2014 AND MAY 31, 2016. THIS RETROSPECTIVE REVIEW WAS ASSOCIATED WITH A QUALITY MANAGEMENT SYSTEM (QMS) COMPLIANCE ACTION PLAN DEVELOPED AND PRESENTED TO FDA TO ADDRESS AN APRIL 10, 2015 WARNING LETTER. APPLIED MEDICAL HAS REVISED ITS MDR REPORTING CRITERIA TO BE MORE CONSERVATIVE AND HAS IMPROVED COMPLAINT HANDLING AND MDR REPORTING PROCESSES. THE REVIEWS ENSURED THAT RECENT REPORTABLE EVENTS WERE APPROPRIATELY IDENTIFIED AND REPORTED TO THE DESIGNATED REGULATORY AUTHORITY(IES). THIS REPORT, WHICH REPRESENTS THE INITIAL AND FINAL REPORTS COMBINED, IS BEING SUBMITTED BASED ON THE FINDINGS OF THAT RETROSPECTIVE REVIEW. IN ACCORDANCE TO 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED UNKNOWN - "THE GENERATOR THAT WE USED ON 3/10 THAT SEEMED TO WORK WELL HAS BEEN GIVING US ISSUES TODAY, SN: (B)(4). THERE WERE MULTIPLE CHEK DEVICE ERRORS AFTER ONLY 2 OR 3 ACTIVATIONS. I CHECKED OUT THE JAWS WHICH LOOKED CLEAN AND IT LOOKED LIKE THEY WERE GRASPING SUFFICIENT TISSUE. DEVICE LOT NUMBER: 1241154. SWITCHED DEVICES. AFTER A FEW SUCCESSFUL ACTIVATIONS, GENERATOR SCREEN WENT BLANK AND EVERY TIME FUSE BUTTON WAS PRESSED, YOU COULD HEAR ALARM TONE BUT COULDN'T SEE ANYTHING ON THE SCREEN. RESTARTED GENERATOR AND IT SEEMED TO BOOT UP FINE, BUT CHECK DEVICE ERRORS." PATIENT STATUS - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164833 EA010, VOYANT ESG 1/BX GEI GEI APPLIED MEDICAL RESOURCES EA010 1233537 10607915131378

    Patients

    Seq Age Sex Outcome Treatment
    1 REPLACEMENT GENERATOR EA010, S/N: (B)(4), EB010