BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 6106356 · Received November 16, 2016

    Report

    Report Number
    1045254-2016-00390
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 2 UN-SEALED SAMPLES, PART NUMBER 1884002, FROM LOT NUMBER 0211682835 WERE RECEIVED FOR ANALYSIS; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE] ON BOTH SAMPLES. WHEN COMPARED TO THE ASSEMBLY DRAWING: VISUALLY, THE TIP OF THE INNER CUTTER AS BROKE OFF BOTH SAMPLES. THE PORTIONS THAT DETACHED MEASURED APPROXIMATELY 0.23 IN LENGTH. WHEN VIEWED UNDER MAGNIFICATION, THE INNER CUTTERS HAD FRACTURED AT THE FIRST PROXIMAL TOOTH VALLEY. THE DEFORMATION OF THE TIPS INDICATES THE INNER CUTTERS IMPACTED THE OUTER TUBES DURING ROTATION. THIS DEFECT MAY OCCUR IF THE BLADE WAS BEING USED IN THE WRONG DIRECTION (FORWARD VS. OSCILLATE), RAN OVER THE RECOMMENDED SPEED DESIGNATED BY LABELED INDICATIONS, OR CAME IN CONTACT WITH AN INAPPROPRIATE MATERIAL. THE RECOMMENDED OPERATING SPEED IS 5,000 RPM IN OSCILLATE MODE / DIRECTION. THE INSTRUCTIONS FOR USE INDICATE THIS BLADE IS USED FOR THE RESECTION OF SOFT TISSUE OR BONE AND WARN, INSERTION OF METAL OBJECTS IN BLADE OR BUR TIP MAY CAUSE THE BLADE OR BUR TO BREAK.

    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 MAXILLARY SINUSOTOMY, THE SURGEON PROCEEDED TO ASK FOR THE SHAVER AND STARTED USING IT BY THE INTERIOR ETHMOID WHEN, IT JUST STOP WORKING. INITIALLY WE THOUGHT THE BLADE WAS CLOGGED, PASSED THE BRUSH THROUGH IT AND IT WAS CLEAR, SO TRIED USING IT AGAIN WITH NO LUCK. A REPLACEMENT BLADE WAS REQUESTED. AS WE STARTED ATTACHING THE OTHER BLADE TO THE SHAVER WE NOTICED THAT THE PATIENT WAS BLEEDING A LITTLE AND STARTED TO SUCTION WHEN WE NOTICED A METAL TIP. AFTER INSPECTING THE ITEM WE CAME TO REALIZE IT WAS THE TIP OF THE INNER BLADE OF THE SHAVER. AFTER REMOVING IT FROM THE PATIENT'S SINUS HE TRIED USING THE NEW TIP THAT WAS PLACED ON THE SHAVER; AS SOON AS THAT SHAVER BEGAN THE SAME THING HAPPENED. THE SECOND TIP LANDED OUTSIDE THE PATIENT. THERE WAS NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756874 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884002 0211682835

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR