BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD® ROTATABLE BLADE

    MDR report key: 4189440 · Received October 21, 2014

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    Report

    Report Number
    3004209178-2014-20085
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT EVALUATION: NO ANALYSIS RESULTS AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION. METHOD: NO TESTING. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURN DATE: NOVEMBER 20, 2014. DATE RECEIVED BY MANUFACTURER: NOVEMBER 21, 2014. PRODUCT EVALUATION: TWO DEVICES WERE RETURNED FOR EVALUATION. ANALYSIS FOUND THAT WHEN COMPARED TO THE ASSEMBLY DRAWING: THE SPIRAL WRAP FAILED AND HYPER EXTENDED AS A RESULT WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. ONE SAMPLE WAS STRETCHED AND THE OTHER SAMPLE HAD THE TIP BROKEN OFF. THE EXTENT OF THE SPIRAL WRAP DAMAGE MAY INDICATE THE DEVICE WAS BEING RUN IN FORWARD DIRECTION HOWEVER THIS CANNOT BE CONFIRMED. THE INSTRUCTIONS FOR USE WARNS: EXCESSIVE PRESSURE APPLIED TO BUR/BLADE MAY CAUSE FRACTURE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. ADDITIONALLY THE INSTRUCTIONS FOR USE WARNS ¿POWERED BLADES SHOULD BE OPERATED IN THE OSCILLATE MODE ONLY. OPERATING IN THE FORWARD MODE MAY CAUSE DAMAGE TO THE BLADE.¿ (B)(4).

    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 DURING A PROCEDURE, 2 RAD 40 BLADES WERE USED; ¿ONE THE TIP IS BROKEN OFF THE OTHER THE INNER PART IS NOT FLUSH WITH THE SHEATH.¿ THERE WAS NO PATIENT IMPACT, PROCEDURE CONTINUED WITH LIKE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668496 RAD® ROTATABLE BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC PUERTO RICO OPERATIONS CO. 1884006HR HG04XM4

    Patients

    Seq Age Sex Outcome Treatment
    1