BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB010, VOYANT 5MM FUSION, 37CM 6/BX

    MDR report key: 6378761 · Received March 4, 2017

    Report

    Report Number
    2027111-2017-01311
    Event Type
    Malfunction
    Date Received
    March 4, 2017
    Date of Event
    April 14, 2015
    Report Date
    March 3, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    00607915117856
    PMA / PMN Number
    8
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING NOTED HEAVY BLOOD AND ESCHAR BUILDUP ON THE JAWS OF THE DEVICE AND BLADE CHANNEL. ENGINEERING WAS UNABLE TO REPLICATE THE DIFFICULT KNOB ROTATION AND ROUGH BLADE ACTUATION. THE CUSTOMER'S LATCHING EXPERIENCE WAS REPLICATED. OTHER SURGEON COMMENTS ARE COSMETIC. THE ROOT CAUSE OF DIFFICULT KNOB ROTATION AND ROUGH BLADE ACTUATION MAY BE EXCESSIVE ESCHAR BUILDUP. THE ROOT CAUSE OF LATCHING ISSUES IS INTERNAL MISALIGNMENT DUE TO ABNORMAL USE. APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE DEVICE ENHANCEMENTS INTENDED TO MINIMIZE THE POTENTIAL FOR THESE TYPES OF EVENTS 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

    LAP LOW ANTERIOR RESECTION- "THE HANDLE WAS DIFFICULT TO OPEN. THERE WAS ALSO RESISTANCE TO CLOSE THE HANDLE. DURING COLD DISSECTION THE KNIFE DIDN'T CUT SMOOTHLY THROUGH THE TISSUE. THE COATING OF THE SHAFT WASN'T FIXED, EASY TO ROTATE AND FLUID WAS CAUGHT BETWEEN THE COATING CAUSING DISCOLORATION. THE ROTATION KNOB WAS ALSO DIFFICULT TO ROTATE." PATIENT STATUS - OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161314 EB010, VOYANT 5MM FUSION, 37CM 6/BX GEI GEI APPLIED MEDICAL RESOURCES 8 1241598 00607915117856

    Patients

    Seq Age Sex Outcome Treatment
    1