BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BUR

    MDR report key: 4765836 · Received May 12, 2015

    Report

    Report Number
    3004209178-2015-08957
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS WAS COMPLETED ON JULY 6, 2015. (B)(4): THE PRODUCT ANALYSIS INDICATES THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. THE DISTAL TIP AND SPIRAL WRAP DID NOT APPEAR TO BE DAMAGED. THE BIOLOGICAL CONTAMINATION WAS CLEANED FROM THE BUR. QUALITY ENGINEER OPERATED THE BUR USING AN IPC CONSOLE AND M5 HANDPIECE. THE RESULT OF THE INVESTIGATION PERFORMED INDICATES THAT THE BUR SHOWED NO OVERHEATING WHEN OPERATED AT THE RECOMMENDED SPEED OF 12K RPM. WHEN THE BUR WAS OPERATED AT 30K, THE BUR WAS HEATING UP AT AN APPROXIMATE RATE OF 1C/SEC. TEMPERATURE AS HIGH AS 54C (34C ORIGINALLY) WAS RECORDED IN 15-20 SEC. INSTRUCTIONS FOR USE WARNS CUSTOMER THAT BURS SHOULD NOT BE OPERATED AT THE SPEED HIGHER THAN RECOMMENDED SPEED. THE BUR LABEL CLEARLY STATES THAT THIS BUR MUST BE OPERATED AT LESS THAN 12K RPM. (B)(4): THE HANDPIECE WAS NOT RETURNED. THEREFORE A PRODUCT ANALYSIS WAS NOT PERFORMED. METHOD: ACTUAL DEVICE EVALUATED, VISUAL INSPECTION, LABELING EVALUATION. RESULTS: THERMAL PROBLEM; CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP WITH THE CUSTOMER INDICATES THAT THE BLADE WAS USED AT 12 ,000 RPM WITH IRRIGATION AS WELL AS SUCTION. G4. THE NEW ADDITIONAL INFORMATION WAS RECEIVED ON MAY 15, 2015.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS. 1899200 ¿ M5 MICRODEBRIDER; 510K NUMBER - K081277. (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

    FOLLOW-UP WITH THE CUSTOMER INDICATES THAT THE BLADE WAS USED AT 12,000 RPM WITH IRRIGATION AS WELL AS SUCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, WHILE USING THE BUR WITH AN M5 HANDPIECE, THE BUR BURNED THE PATIENT'S LIP. FOLLOW-UP WITH THE CUSTOMER INDICATES THAT IT WAS A SECOND DEGREE BURN ON THE NASAL FLOOR AND LIP OF THE PATIENT. TOPICAL BURN MEDICATION WAS ADMINISTERED TO PREVENT INFECTION AND IMPROVE HEALING. THE CUSTOMER STATED THAT THEY WERE DONE WITH THE BUR AT THAT POINT SO THEY DID NOT NEED TO REPLACE THE BUR. THE CUSTOMER ALLEGED THE ISSUE WAS ONLY WITH THE BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309097 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1885061HS HG058JM

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention