BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB215, VOYANT MARYLAND FUSION 37CM, 6/BX

    MDR report key: 9837754 · Received March 16, 2020

    Report

    Report Number
    2027111-2020-00423
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    January 8, 2020
    Report Date
    March 16, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    00607915139353
    PMA / PMN Number
    K193292
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE BLADE REMAINED IN THE LOWER JAW OF THE DEVICE. ENGINEERING DISASSEMBLED THE EVENT UNIT AND OBSERVED THAT THE BLADE PUSHER, AN INTERNAL COMPONENT OF THE DEVICE, WAS DAMAGED. BASED ON THE CONDITION OF THE RETURNED UNIT, THE REPORTED EVENT WAS CAUSED BY THE DAMAGED BLADE PUSHER. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THIS REPORT REPRESENTS A COMBINED INITIAL AND FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAP. SALPINGECTOMY. INCIDENT DESCRIPTION: "[SURGEON] OPENED A VOYANT MARYLAND FUSION AND THE JAWS WOULD NOT OPEN. ANOTHER DEVICE WAS OPENED AND USED." ADDITIONAL INFORMATION WAS RECEIVED FROM APPLIED MEDICAL HEALTH SYSTEM SPECIALIST, VIA E-MAIL ON JANUARY 24TH, 2020: THE PROCEDURE WAS A LAP SALPINGECTOMY. NO AUDIBLE NOISE OR VISUAL DAMAGE WAS OBSERVED TO THE DEVICE PRIOR TO THIS EXPERIENCE. HOSPITAL CONTACT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED FROM APPLIED MEDICAL HEALTH SYSTEM SPECIALIST, VIA TELEPHONE ON FEBRUARY 28TH, 2020 AT 1009; REP. STATED THAT THE SCRUB TECH WHO WAS ORIGINALLY ASSISTING IN THE CASE QUIT WORKING AT THE HOSPITAL SHORTLY AFTER THE CASE WAS COMPLETED. WHEN THE REP. TRIED TO FIND OTHER SCRUB TECHS AND OTHER PEOPLE PRESENT DURING THE SURGERY, THE ONLY INFORMATION THAT COULD BE PROVIDED TO HIM WAS THAT THEY WERE UNSURE AS TO EXACTLY WHAT HAPPENED. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301303 EB215, VOYANT MARYLAND FUSION 37CM, 6/BX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES EB215 1373404 00607915139353

    Patients

    Seq Age Sex Outcome Treatment
    1