BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5774163 · Received July 6, 2016

    Report

    Report Number
    2027111-2016-00493
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 7, 2016
    Report Date
    January 17, 2017
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF 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. ENGINEERING PERFORMED VISUAL AND FUNCTIONAL TESTING ON THE DEVICE. UPON INSPECTION, ENGINEERING NOTED BLOOD AND ESCHAR BUILDUP ON THE JAWS AND IN THE BLADE CHANNEL OF THE DEVICE. IT WAS ALSO NOTED THAT VARIOUS COMPONENTS OF THE DEVICE WERE DAMAGED AND THE JAW GAP WAS GREATER THAN SPECIFIED. DURING FUNCTIONAL TESTING, ENGINEERING ACTIVATED THE DEVICE ON SALINE SOAKED PAPER TOWEL AND CONCLUDED THAT THE SEAL CYCLE COMPLETED SUCCESSFULLY. IT IS POSSIBLE THAT THE ROOT CAUSE OF INSUFFICIENT HEMOSTASIS COULD BE RELATED TO THE LARGE JAW GAP; HOWEVER, ENGINEERING WAS UNABLE TO VERIFY IF THE DAMAGE TO THE DEVICE HAPPENED DURING THE PROCEDURE OR DURING SHIPMENT POST-PROCEDURE. THE ROOT CAUSE OF THE STICKING ON TISSUE CAN BE ATTRIBUTED TO EXCESSIVE BLOOD AND ESCHAR BUILD UP. THE INSTRUCTIONS FOR USE (IFU) STATES, "FOR OPTIMAL PERFORMANCE, KEEP THE JAW SURFACES CLEAN. USE GAUZE PAD SOAKED WITH STERILE WATER OR SALINE TO REMOVE ESCHAR." ALTHOUGH THE ROOT CAUSE OF INSUFFICIENT HEMOSTASIS COULD NOT BE CONFIRMED, APPLIED MEDICAL IS CURRENTLY IMPLEMENTING CORRECTIVE ACTIONS WITHIN A CORRECTIVE AND PREVENTATIVE ACTION REPORT TO MITIGATE THIS TYPE OF EVENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED. 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

    HALS LAR- "AT ACTIVATION #40 SURGEON NOTED THAT THE HANDLE OF THE DEVICE SEEMED TO STICK FOR AN ACTIVATION OR TWO. THIS DID NOT HAPPEN AGAIN DURING THE CASE. SURGEON HAD ACTIVE PUMPING BLEEDERS AFTER ATTEMPTED SEAL ON ACTIVATION #55. SURGEON CONTINUED TO TRY AND SEAL VESSEL THROUGH ACTIVATION #69, AND HAD MULTIPLE PUMPING/ACTIVE BLEEDERS THROUGHOUT THESE ACTIVATIONS. ALL OF THESE ACTIVATIONS WERE IN AN ATTEMPT TO SEAL THE IMA. ACTIVATIONS #70-#92 WERE ACTIVATIONS TO CONTROL BLEEDING. JAWS WERE ONLY CLEANED ONCE AFTER ACTIVATION #84. AFTER ACTIVATION #92 SURGEON WAS OPENED LIGATURE TO CONTINUE CASE. REP HAS (B)(4) CASE FORM THAT CAN BE SUBMITTED IF NEEDED." PATIENT STATUS - NO PATIENT INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 15JULY2015: THE JAWS WERE STICKING TO THE TISSUE WHEN ATTEMPTING TO OPEN THE JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425594 EB010, VOYANT 5MM FUSION 37CM, 6/BX GEI GEI AMR EB010 1262579 00607915117856

    Patients

    Seq Age Sex Outcome Treatment
    1