BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - IPC® M5 AND M4 30K

    MDR report key: 4859913 · Received June 22, 2015

    Report

    Report Number
    1045254-2015-00212
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ANALYSIS WAS COMPLETE ON JULY 10, 2015. SUPPL THE PRODUCT ANALYSIS FOR BUR 1884070RTD TAP DIAMOND 70DG 4MM 30K FOUND EVIDENCE OF BIOLOGICAL CONTAMINANTS (BASED ON THE REACTIVITY WITH HYDROGEN PEROXIDE). THE DISTAL TIP AND SPIRAL WRAP DID NOT APPEAR TO BE DAMAGED. IRRIGATION TUBING WAS SUCCESSFULLY AND FIRMLY ATTACHED TO THE IRRIGATION BARB ON THE BUR HUB. EXCCESSIVE BIOLOGICAL CONTAMINATION BLOCKED THE IRRIGATION PORTS AT THE DISTAL TIP OF THE BUR OUTER TUBE THUS PREVENTING A TEST OF IRRIGATION FLOW. THE IRRIGATION PORT BLOCKAGE WAS MOST LIKELY DUE TO OPERATION OF THE BUR WITHOUT IRRIGATION FLOWING. THE INSTRUCTIONS FOR USE OF THE PRODUCT ADVISE USERS TO, "USE ADEQUATE IRRIGATION FROM A SEPARATE USER-PROVIDED IRRIGATING SOURCE. THE USE OF AN ACCESSORY WITHOUT IRRIGATION MAY CAUSE AN INORDINATE AMOUNT OF HEAT BUILDUP RESULTING IN THERMAL INJURY TO TISSUE". METHOD: ACTUAL DEVICE EVALUATED, VISUAL INSPECTION, MICROSCOPIC INSPECTION, LABELING EVALUATION. RESULTS: OPERATIONAL PROBLEM, THERMAL PROBLEM. CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: MICRODEBRIDER 1899200 M5 ROHS; 510K: K081277; SERIAL # (B)(4); LOT# 208769447; MFR DATE: 2014-09-22. (B)(4). THE PRODUCT ANALYSIS OF THE DIAMOND BUR (BUR 1884070RTD TAP DIAMOND 70DG 4MM 30K) HAS NOT STARTED AT THIS TIME. THE M5 HANDPIECE (MICRODEBRIDER 1899200 M5 ROHS, CONCOMITANT DEVICE) IS NOT BEING RETURNED BY THE FACILITY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SALES REP STATED THAT DURING A PROCEDURE, THE BUR (1884070RTD) WAS BEING USED WITH AN M5 HANDPIECE, AND THE IRRIGATION TUBING (THAT CAME FROM ANOTHER HANDPIECE USED JUST PRIOR TO THIS ONE IN THE SAME PROCEDURE) KEPT FALLING OFF. THE SURGEON BEGAN TO DRILL AND THE BUR / M5 STARTED TO SMOKE WITHIN 1 MINUTE. THEY DISCOVERED THE IRRIGATION HAD DETACHED BECAUSE THE ANESTHESIOLOGIST NOTICED SOMETHING WAS SPLASHING ON HIM. HEATHER REPORTED THE PATIENT WAS NOT HARMED OR IMPACTED. THE SURGEON WAS ABLE TO OPEN A NEW IRRIGATION SET AND CONTINUE WITH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403905 XPS® BUR - IPC® M5 AND M4 30K BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884070RTD 0209299575

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR