BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNGSTEN MICRO NEEDLE 3CM, STRAIGHT, 10 PK

    MDR report key: 15758334 · Received November 9, 2022

    Report

    Report Number
    3007216334-2022-00014
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 20, 2022
    Report Date
    November 9, 2022
    Manufacturer
    WICKIMED SUPPLY COMPANY LTD
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    VOLUNTARY DISTRIBUTOR REPORT THE MANUFACTURER, WICKIMED SUPPLY COMPANY LTD, IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    VOLUNTARY DISTRIBUTOR REPORT THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 138505-10, TUNGSTEN MICRO NEEDLE 3CM, STRAIGHT, WAS BEING USED DURING A SPINE SURGERY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿DURING USE OF THIS PRODUCT, A MEDICAL ACCIDENT OCCURRED IN WHICH AN INSULATED TUBE FELL OFF AND ENTERED THE BODY. FORTUNATELY, THE INSULATING TUBE WAS SUCKED OUT AND REMAINED INSIDE THE BODY.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE TUBE WAS ¿SUCKED OUT BY SUCTION¿ AND WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TUNGSTEN MICRO NEEDLE AND THE SURGERY WAS EXTENDED FOR AN UNKNOWN AMOUNT OF SURGERY TIME. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿RECOVERING¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2951283 TUNGSTEN MICRO NEEDLE 3CM, STRAIGHT, 10 PK ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI WICKIMED SUPPLY COMPANY LTD P2139004

    Patients

    Seq Age Sex Outcome Treatment
    1 Male