BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN

    MDR report key: 15681905 · Received October 27, 2022

    Report

    Report Number
    3000719969-2022-00003
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Report Date
    December 21, 2022
    Manufacturer
    OLEN MEDICAL CORP
    Product Code
    GEI
    UDI-DI
    00841785102035
    PMA / PMN Number
    K130669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUS FOLLOW UP STATED THAT THE DEVICE WAS AVAILABLE FOR EVALUATION. HOWEVER, THIS WAS INCORRECTLY CHECKED AS THE DEVICE WAS NOT AVAILABLE FOR SYMMETRY/OLSEN TO EVALUATE. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    AFTER MULTIPLE ATTEMPTS, THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND PICTURES WERE NOT PROVIDED. THE CUSTOMER WAS NOT ABLE TO PROVIDE A LOT NUMBER OR DATE OF PURCHASE TO COMPLETE A REVIEW OF DEVICE HISTORY RECORDS AND TESTING COMPLETED PRIOR TO SHIPPING. WITHOUT ANY OF THIS INFORMATION, A TRUE INVESTIGATION CANNOT TAKE PLACE. THE CUSTOMER DID STATE, HOWEVER, THAT THEY WERE USING THE DEVICE AT A SETTING OF 100. PER THE PRODUCT IFU, THE DEVICE SHOULD BE USED AT THE LOWEST SETTING POSSIBLE TO GET THE DESIRED RESULTS. THIS IS AN ISOLTED EVENT, AND BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR INFORMATION PERTINENT TO THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    TO THIS POINT, WE HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION FROM THE CUSTOMER. WE WILL CONTINUE TO FOLLOW UP WITH THE CUSTOMER. THIS IS THE FIRST COMPLAINT RECORDED WITH 152 SOLD OF ALL LOTS. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE WE HAVE RECEIVED ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT THE 12101 HAS BURNED TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2721570 OLSEN MONOPOLAR FORCEPS GEI OLEN MEDICAL CORP 12101 00841785102035

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown