BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN

    MDR report key: 10775061 · Received November 2, 2020

    Report

    Report Number
    3000719969-2020-00005
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    September 27, 2020
    Report Date
    January 4, 2021
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    UDI-DI
    00841785110061
    PMA / PMN Number
    K111262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TWO LOT NUMBERS OF 90020 WERE RETURNED LOT# 116966 AND LOT# 112530. IT IS UNKNOWN IF BOTH OR ONE WERE INVOLVED IN THE REPORTED EVENT. LOT# 116966 WAS PURCHASED IN APRIL 2020 AND LOT# 112530 WAS PURCHASED IN JULY 2019. THE RETURNED DEVICES ARE STILL BEING EVALUATED BY THE MANUFACTURING LOCATION. ADDITIONALLY, WE HAVE REQUESTED SOME ADDITIONAL INFORMATION FROM THE CUSTOMER TO HELP WITH OUR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE WE HAVE COMPLETED OUR INVESTIGATION OR SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED ANY DETAILS, INCLUDING THE PART NUMBER INVOLVED AS THE CUSTOMER HAS NOT RESPONDED. PART 90020 WAS CHOSEN FOR THE REPORT AS IT IS PURCHASED THE MOST OFTEN BY OUR DISTRIBUTOR IN (B)(4). THERE HAS BEEN A TOTAL OF (B)(4) SOLD OF THIS PART NUMBER WITH ON ADDITIONAL COMPLAINT RECORDED FOR THE CORD SHORTING OUT, AND NO LONGER WORKING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE FURTHER DETAILS ARE RECEIVED, OR IF WE DECIDE TO CLOSE THE COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT DURING THE MIDDLE OF THE SURGERY, THE CABLE BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238114 OLSEN MONOPOLAR CABLE GEI OLSEN MEDICAL LLC 90020 00841785110061

    Patients

    Seq Age Sex Outcome Treatment
    1