BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB215, VOYANT MARYLAND FUSION 37CM, 6/BX

    MDR report key: 18976044 · Received March 25, 2024

    Report

    Report Number
    2027111-2024-00469
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    June 20, 2023
    Report Date
    July 29, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    00607915139353
    PMA / PMN Number
    K200598
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DEVICE HAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE RETURNED UNIT, WHICH CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF THE JAWS NOT OPENING. ENGINEERING OBSERVED THAT THE PULL TUBE, AN INTERNAL COMPONENT TO FACILITATE THE MOVEMENT OF THE JAW, WAS BENT. BASED ON THE CONDITIONS OF THE RETURNED UNIT, THE REPORTED EVENT WAS LIKELY CAUSED BY ESCHAR BUILDUP WITHIN THE PULL TUBE, WHICH PREVENTED THE JAWS FROM OPENING.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP. SIGMA. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4). COMPLAINT 2 OF 2: (B)(4). AFTER 45 MINUTES IN THE PROCEDURE THE SURGEON WAS UNABLE TO OPEN THE JAWS. ONLY WITH A LOT OF FORCE. HE DECIDED TO OPEN AN NEW EB215 TO BE ON THE SAFE SIDE. AFTER ANOTHER 30 MINUTES THE SAME OCCURS AND HE DECIDED TO USE THE [BRAND NAME REDACTED]. HIS SUGGESTION WAS THAT THE DEVICE WOULD STICK TOO QUICKLY. AND IN HIS EYES IT IS TO DANGEROUS TO WORK UNDER THIS CIRCUMSTANCES. INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 3JUL23: THE HANDLE WAS GETTING STUCK IN THE LATCHED POSITION PREVENTING THE JAWS FROM OPENING. THERE WAS TISSUE DAMAGE AND TISSUE BLEEDING WHEN THE DEVICE WAS BEING REMOVED. THIS PROBLEM WAS OBSERVED 3 TO 5 TIMES. THE DEVICE WAS BEING USED FOR 30 MINUTES. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 23OCT23: I HAVE NOT MORE INFORMATION AS I HAD SENT YOU IN ATTACHED EMAIL. INTERVENTION: THE SURGENON USED ANOTHER COMPETITOR DEVICE. PATIENT STATUS: NOTHING.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP. SIGMA. EVENT DESCRIPTION: COMPLAINT 1 OF 2: 2023-001734 [MFR #2027111-2024-00468]. COMPLAINT 2 OF 2: 2023-001735 [MFR #2027111-2024-00469]. AFTER 45 MINUTES IN THE PROCEDURE THE SURGEON WAS UNABLE TO OPEN THE JAWS. ONLY WITH A LOT OF FORCE. HE DECIDED TO OPEN AN NEW EB215 TO BE ON THE SAFE SIDE. AFTER ANOTHER 30 MINUTES THE SAME OCCURS AND HE DECIDED TO USE THE [BRAND NAME REDACTED]. HIS SUGGESTION WAS THAT THE DEVICE WOULD STICK TOO QUICKLY. AND IN HIS EYES IT IS TO DANGEROUS TO WORK UNDER THIS CIRCUMSTANCES. INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 3JUL2023: THE HANDLE WAS GETTING STUCK IN THE LATCHED POSITION PREVENTING THE JAWS FROM OPENING. THERE WAS TISSUE DAMAGE AND TISSUE BLEEDING WHEN THE DEVICE WAS BEING REMOVED. THIS PROBLEM WAS OBSERVED 3 TO 5 TIMES. THE DEVICE WAS BEING USED FOR 30 MINUTES. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 23OCT2023: I HAVE NOT MORE INFORMATION. INTERVENTION: THE SURGEON USED ANOTHER COMPETITOR DEVICE. PATIENT STATUS: NOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409303 EB215, VOYANT MARYLAND FUSION 37CM, 6/BX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES EB215 1478251 00607915139353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERATOR