BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN

    MDR report key: 9900667 · Received March 30, 2020

    Report

    Report Number
    3000719969-2020-00003
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 12, 2020
    Report Date
    March 30, 2020
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    UDI-DI
    00841785102912
    PMA / PMN Number
    K130669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. THE CUSTOMER STATED THAT THEY WERE USING POWER SETTINGS OF 15 OR 20. THE DEVICE WAS TESTED ON THESE SETTING AND FUNCTIONED AS INTENDED. THE GENERATOR WAS TURNED UP TO 40W AND THE REPORTED ARCING THAT THE CUSTOMER REPORTED COULD NOT DUPLICATED. A TRUE ROOT CAUSE CANNOT BE ACCURATELY DETERMINED WITH THE INFORMATION PROVIDED, MOST LIKELY THE BURN OCCURRED DUE TO USER ERROR AS THE FORCEPS WERE FUNCTIONING AS INTENDED. THERE HAS BEEN A TOTAL OF (B)(4) INSTRUMENTS SOLD WITH NO ADDITIONAL COMPLAINT RECORDED FOR THIS ISSUE. THIS IS AN ISOLATED EVENT. BASED ON THE ABOVE INFORMATION, THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR THE NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A LEFT SUBLINGUAL GLAND EXCISION AND TRANSORAL EXCISION OF SUBMENTAL MASS, THE SURGEON WAS CAUTERIZING A VESSEL UNDERNEATH THE PATIENT'S TONGUE. THE FORCEPS ARCED AND BURNT THE PATIENT'S LIP. THERE WAS A DELAY IN THE PROCEDURE TO TEND TO THE BURN, BUT THERE WAS NO ADDITIONAL PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365296 OLSEN ADSON BIPOLAR FORCEPS GEI OLSEN MEDICAL LLC 20-1080K 113883 00841785102912

    Patients

    Seq Age Sex Outcome Treatment
    1