BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5847273 · Received August 4, 2016

    Report

    Report Number
    2027111-2016-00553
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    July 8, 2016
    Report Date
    June 8, 2017
    Manufacturer
    AMR
    Product Code
    GEI
    UDI-DI
    00607915117856
    PMA / PMN Number
    K141288
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS RECEIVED THE INCIDENT DEVICE AND THE PRODUCT HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT'S DEVICE KEY, THE PART OF THE DEVICE THAT CONNECTS TO THE GENERATOR, WAS RETURNED FOR EVALUATION. ENGINEERING ANALYZED THE DEVICE ACTIVATION LOGS BY EXTRACTING THE LOGS FROM A MICROCHIP IN THE DEVICE KEY. THE DEVICE ACTIVATION LOGS SHOWED 23 ACTIVATIONS, 4 OF WHICH SHOWED THAT THE GENERATOR GAVE AN ALARM AND STOPPED ENERGY OUTPUT, THUS, CONFIRMING PART OF THE COMPLAINANT'S EVENT. THESE ALARMS ARE A SAFETY-BY-DESIGN FEATURE. SINCE ONLY THE DEVICE KEY WAS RETURNED, ENGINEERING WAS UNABLE TO CONFIRM OR REPLICATE THE COMPLAINANT'S EXPERIENCE OF TISSUE STICKING OR INSUFFICIENT HEMOSTASIS. IN THE ABSENCE OF THE SUBJECT UNIT, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. ALTHOUGH THE EXACT 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.

    Description of Event or Problem · 1

    LAP COLOSTOMY; "DOCTOR ORIGINALLY USED A STAPLER FIRED 1 LOADS. WHEN THEY NOTICED THE COLON WAS NOT COMPLETELY SEALED THEY DECIDED TO USE VOYANT. THE DOCTOR USED AN EB010 AND THE 'CHECK DEVICE' ERROR CODE WOULD APPEAR ON THE SCREEN AFTER THE THIRD OR FOURTH ACTIVATION. A SECOND HAND PIECE WAS USED AND THE SAME ERROR APPEARED ON THE GENERATOR. THE GENERATOR WAS SWITCHED OUT AND THE SECOND HAND PIECE PERFORMED WITHOUT PRODUCING THE 'CHECK DEVICE' ERROR CODE. A SECOND CER 2016-0347 (HAND PIECE RETURNING AND THE KEY TO THE SECOND HAND PIECE) HAS BEEN FILLED OUT FOR THE GENERATOR THAT HAD AN ISSUE. STICKING DID OCCUR THERE WERE 2 SMALL BLEEDERS THAT WERE UNDER CONTROL. JAWS WERE STICKING AFTER ONLY 4 ACTIVATIONS. JAWS WERE STEAM CLEANED. TISSUE WAS OMENTUM AROUND THE COLON WITH A VESSEL IN THE TISSUE AND BOWEL." PATIENT STATUS: "OK" ADDITIONAL INFORMATION RECEIVED ON JULY 13, 2016: FROM MY VANTAGE POINT I ESTIMATE THE SURGEON EXPERIENCED GENERATOR ERRORS APPROXIMATELY 1-2CM FROM THE DISTAL END OF THE STAPLE LINE. I BELIEVE THAT THE SURGEON ACTIVATED VOYANT ON A SMALL REMNANT OF BOWEL, VESSELS, AND OTHER TISSUE, THAT REMAINED WHEN THE STAPLE LOAD DID NOT COMPLETELY CROSS/DIVIDE THE BOWL. IT DID APPEAR THAT THE INTER-LUMEN OF THE BOWEL WAS COMPLETELY OCCLUDED WITH THE STAPLER AND VOYANT WAS ONLY USED TO TRANSECT THE LAST SMALL SECTION OF THE EXTERIOR WALL OF THE BOWEL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON JULY 13, 2016 AT 11:40 AM: THE SURGEON EXPERIENCED GENERATOR ERRORS APPROXIMATELY 1-2 CM FROM THE DISTAL END OF THE STAPLE LINE. I BELIEVE THAT THE SURGEON ACTIVATED VOYANT ON A SMALL REMNANT OF BOWEL, VESSELS, AND OTHER TISSUE, THAT REMAINED WHEN THE STAPLE LOAD DID NOT COMPLETELY CROSS/DIVIDE THE BOWL. IT DID APPEAR THAT THE INTER-LUMEN OF THE BOWEL WAS COMPLETELY OCCLUDED WITH THE STAPLER AND VOYANT WAS ONLY USED TO TRANSECT THE LAST SMALL SECTION OF THE EXTERIOR WALL OF THE BOWEL. ADD INFO RECEIVED VIA E-MAIL FROM SALES REP ON MARCH 29, 2017 - I KNOW WE DID NOT KEEP THE HAND PIECE FOR THE SECOND DEVICE BECAUSE WE DETERMINED THE PROBLEM TO BE THE GENERATOR. I BELIEVE THE STICKING OCCURRED ON THE SECOND DEVICE AS WE COULD NOT GET THE FIRST DEVICE TO WORK PROPERLY WITH THE FAULTY GENERATOR, BUT IT HAS BEEN SO LONG AGO, I REALLY COULDN'T BE 100% POSITIVE. ADD INFO RECEIVED VIA E-MAIL FROM SALES REP ON MARCH 31, 2017 - . "I BELIEVE I BAGGED AND RETURNED THE 1ST DEVICE AND KEY BECAUSE I THOUGHT IT HAD AN ISSUE, BUT IN REALITY IT WAS THE GENERATOR, WHICH WAS SWAPPED OUT. THE 2ND DEVICE WAS USED TO COMPLETE THE CASE WITH THE NEW GENERATOR, HAD STICKING ISSUES, BUT WAS NOT RETURNED, ONLY THE KEY. I WISH I WOULD HAVE KEPT THE SECOND DEVICE AS WELL, BUT PRESSURE WAS HIGH IN THE OR ROOM AND I WAS ONLY ABLE TO SALVAGE THE KEY. I HOPE THIS CLEARS THINGS UP, BUT PLEASE LET ME KNOW IF YOU HAVE ANY ADDITIONAL QUESTIONS. AS WE DISCUSSED PREVIOUSLY, I'M SORRY I AM NOT 100% SURE AS THIS HAS BEEN SO LONG AGO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498213 EB010, VOYANT 5MM FUSION 37CM, 6/BX GEI GEI AMR EB010 1265226 00607915117856

    Patients

    Seq Age Sex Outcome Treatment
    1 Other