BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5777721 · Received July 7, 2016

    Report

    Report Number
    2027111-2016-00504
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Report Date
    June 8, 2016
    Manufacturer
    AMR
    Product Code
    GEI
    UDI-DI
    00607915117856
    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING NOTED BLOOD AND ESCHAR ON THE PROXIMAL END OF THE UPPER JAW AND DISTAL END OF THE BLADE CHANNEL. DURING FUNCTIONAL TESTING, ENGINEERING OBSERVED FRICTION WHEN UNLATCHING WHEN THE BLADE WAS ACTUATED BETWEEN LATCHES AND FOUND THAT THE BLADE WAS NOT FULLY RETURNING TO THE RETRACTED POSITION AUTOMATICALLY. HOWEVER, ENGINEERING WAS UNABLE REPLICATE THE EXPERIENCE SINCE THE JAWS WERE NOT LOCKED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED AS ENGINEERING WAS UNABLE TO REPLICATE THE EXPERIENCE. IN THE EVENT THAT THE JAWS BECOME LOCKED DUE TO THE BLADE BEING STUCK, THE INSTRUCTIONS FOR USE (IFU) STATES, "IF THE BLADE DOES NOT RETURN TO THE STARTING POSITION AUTOMATICALLY, MANUALLY PUSH THE BLADE LEVER FORWARD TO RETRACT THE BLADE." ALTHOUGH THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED, APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. ADDITIONAL INFORMATION REQUESTED AND RECEIVED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    DEVICE STAYED BLOCKED IN THE CLOSED POSITION. ADDITIONAL INFORMATION RECEIVED VIA EMAIL JUNE 16, 2016: "THE SALES REP HAS CONFIRMED THAT HE HAS ORGANIZED A VISIT TO THE HOSPITAL AND WILL MEET THE USER DURING WEEK OF (B)(6). (CART OF A GENERATOR WILL BE DELIVERED THAT WEEK)." ADDITIONAL INFORMATION RECEIVED VIA EMAIL JULY 5, 2016 AT 2:48 AM FROM (B)(6): "PLEASE CONFIRM THE PRODUCT IS RETURNING. FORM STATES ?1 EACH? IS RETURNING, BUT YES/NO BOX IS NOT CHECKED. YES. WHAT IS THE PATIENT STATUS? OK. WAS THE HANDLE GETTING STUCK IN THE LATCHED POSITION PREVENTING THE JAWS FROM OPENING? OR, WAS THE HANDLE ABLE TO BE MOVED, BUT THE JAWS WOULD NOT RESPOND? HANDLE WAS STUCK IN LATCHED POSITION PREVENTING JAWS FROM OPENING. WAS THE BLADE LEVER STILL ENGAGED WHEN THE JAWS WERE LOCKING? NO SPECIFIC RESPONSE BUT THE BLADE WAS NOT STUCK. WAS THE SURGEON ABLE TO RELEASE THE JAWS FROM THE TISSUE? YES IF SO, HOW? THE SURGEON MOVED APART THE HANDLE WITH HIS HANDS BY FORCE. HOW LONG HAD THE DEVICE BEEN USED BEFORE THE EXPERIENCE WAS OBSERVED (APPROX. # OF ACTIVATIONS)? AT THE START OF THE PROCEDURE, AFTER AROUND 10 ACTIVATIONS. WAS THE SURGEON ABLE TO FIND A RESOLUTION? IF SO, HOW? THE SURGEON MOVED APART THE HANDLE WITH HIS HANDS AND CHANGED DEVICE IMMEDIATELY TO NOT TAKE ANY RISK." PATIENT STATUS: "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429048 EB010, VOYANT 5MM FUSION 37CM, 6/BX GEI GEI AMR EB010 1262578 00607915117856

    Patients

    Seq Age Sex Outcome Treatment
    1