BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3190365 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02530
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HRX
    PMA / PMN Number
    K993021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A ¿MED PROCEDURE FOR A DISK HERNIATION. IT IS REPORTED THAT THE SCOPE HAD A DARK POOR IMAGE. THE INCIDENT WAS CONFIRMED AT THE BEGINNING OF THE SURGERY. THE SCOPE WAS REPLACED WITH ANOTHER ONE, AND THE SURGERY WAS CONTINUED. THIS INCIDENT DELAYED THE SURGERY LESS THAN 15 MINUTES. S<(>&<)>R CONFIRMED THAT THE SHAFT OF THE SCOPE WAS BENT GENTLY.¿ NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291121 ARTHROSCOPE ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC NA 789940

    Patients

    Seq Age Sex Outcome Treatment
    1