BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAD® BLADE

    MDR report key: 4214679 · Received October 30, 2014

    Report

    Report Number
    1045254-2014-00280
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE HAS BEEN RECEIVED AND ANALYSIS IS CURRENTLY UNDERWAY. (B)(4).

    Additional Manufacturer Narrative · 1

    AS RECEIVED CONDITION: RECEIVED 1 SAMPLE(S), PART NUMBER 1884012HR. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0,65 TO 5,0 MAGNIFICATION SETTINGS). OBSERVATIONS: WHEN COMPARED TO THE ASSEMBLY DRAWING 66500090 REVISION G: THE MIDDLE SPIRAL WRAP FAILED AND THE TIP BROKE OFF AS A RESULT WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS DEFORMATION OF THE FRONT HUB THAT IS CONSISTENT WITH EXCESS PRESSURE BEING APPLIED WHILE IN THE HANDPIECE. 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 68E4066 REVISION K 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.¿ THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING THEREFORE MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE. METHOD ¿ ACTUAL DEVICE EVALUATED; LABELING EVALUATION; VISUAL INSPECTION FDA; MICROSCOPIC INSPECTION; RESULTS: STRESS PROBLEM. CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT.

    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 TO ME THAT THE BLADE BROKE AND A PIECE OF IT FELL IN THE MAXILLARY SINUS. THAT PIECE WAS RETRIEVED WITH AN INSTRUMENT CAUSING A TEN MINUTE DELAY. IT WAS NOTED THAT EARLIER IN THE CASE, THE SCRUB NURSE TOOK THE STYLET TO CLEAN OUT THE BLADE AND THE SHAVER PEDAL WAS ACCIDENTALLY PRESSED DOWN, CAUSING THE BLADE TO GET STUCK. THE CUSTOMER THOUGHT THAT THIS COULD HAVE POSSIBLY DONE SOMETHING INTERNALLY BUT WASN¿T CERTAIN. AFTER THE STYLET WAS REMOVED IT SEEMED TO BE WORKING FINE FOR A PORTION OF THE CASE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695573 RAD® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884012HR

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention