BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR

    MDR report key: 4887991 · Received July 2, 2015

    Report

    Report Number
    1045254-2015-00220
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    May 5, 2015
    Report Date
    June 9, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS WAS COMPLETED ON JULY 15, 2015. THE PRODUCT ANALYSIS INDICATES THAT THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. A SMALL PERCENTAGE OF DIAMOND PARTICLES WERE MISSING FROM THE PLATING THAT BONDS THEM TO THE BUR HEAD WHICH INDICATES EXCESS PRESSURE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. INSTRUCTIONS FOR USE WARN, "EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE WHICH MAY CAUSE INJURY". METHOD: FDM ¿ ACTUAL DEVICE EVALUATED; VISUAL INSPECTION; LABELING EVALUATION. RESULT: STRESS PROBLEM. CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. INITIAL REPORTER: DR. (B)(6). (B)(4). PRODUCT EVALUATION: ANALYSIS OF DEVICE EXPECTED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY TO TREAT A CHOLESTEATOMA, THE DIAMONDS FELL FROM THE DEVICE DURING ITS USE. THE DIAMOND FRAGMENTS FELL INTO THE PATIENT¿S BODY BUT THE FRAGMENTS DID NOT REMAIN IN THE PATIENT BODY. THEY FRAGMENTS WERE RETRIEVED WITHOUT ANY ADDITIONAL PROCEDURE OR ADDITIONAL EQUIPMENT. AT THE END OF THE SURGERY THE PATIENT WAS FINE. THERE WERE NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429887 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 31114065 0206937738

    Patients

    Seq Age Sex Outcome Treatment
    1