BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK

    MDR report key: 5276526 · Received December 9, 2015

    Report

    Report Number
    9611253-2015-00118
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    November 13, 2015
    Report Date
    March 30, 2016
    Manufacturer
    NAKANISHI INC.
    Product Code
    HBC
    PMA / PMN Number
    K132264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON MARCH 3, 2016, NAKANISHI VISITED THE HOSPITAL FOR THE PATIENT INFORMATION AND RECEIVED THE INFORMATION ABOUT THE PATIENT AGE AND SEX ONLY. THE HOSPITAL DID NOT HAVE THE INFORMATION OF THE PATIENT'S IDENTIFIER AND WEIGHT. UPON RECEIPT FROM THE HOSPITAL OF THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED : NAKANISHI EXAMINED THE DEVICE HISTORY RECORD FOR THE SUBJECT (B)(6) DEVICE [SERIAL NUMBER (B)(4)]. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. NAKANISHI CONNECTED THE RETURNED DEVICE TO A COMPANY-OWNED UNIT (P200-CU-100) AND LEFT IT AS IT IS ABOUT FOR 30 MINUTES. NAKANISHI DID NOT OBSERVE ACTIVATION OF THE MOTOR AS THE USER COMPLAINED ABOUT. NAKANISHI THEN PRESSED THE FOOT CONTROL TO ROTATE THE MOTOR. THE MOTOR DID NOT START ROTATING WITH THE ERROR MESSAGE "E03" DISPLAYED ON THE MONITOR. NOTE) E03 = FAILURE OF SENSOR SIGNAL SYSTEM HOWEVER, THE MOTOR OPERATED NORMALLY WITHOUT THE ERROR MESSAGE "E03", WHEN NAKANISHI PRESSED THE FOOT CONTROL WHILE BENDING THE BUSH ON THE MOTOR SIDE WITH A HAND. NAKANISHI CLEANED THE MOTOR IN A THERMO-DISINFECTOR PRODUCED BY SAKURA SEIKI CO., LTD. AND DISASSEMBLED THE MOTOR. AFTER THE CLEANING, NAKANISHI CARRIED OUT AN OPERATION CHECK/CONTINUITY CHECK. THERE ARE NO ABNORMALITIES OBSERVED SUCH AS AN UNINTENDED ACTIVATION AND ALL OF THE 10 LEADS IN THE MOTOR CONDUCTED NORMALLY. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS : NAKANISHI DID NOT IDENTIFY THE CAUSE OF MALFUNCTION OF THE RETURNED DEVICE BECAUSE NAKANISHI WERE NOT ABLE TO REPLICATE THE PHENOMENON AT THE TIME OF THE EVENT AND DID NOT OBSERVE ANY ABNORMALITIES IN THE EVALUATIONS. NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO THE DOCTOR AND RETURNED THE DEVICE TO THE DOCTOR FOR CONTINUOUS USE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, NAKANISHI RECEIVED A PHONE CALL FROM A HOSPITAL ABOUT MALFUNCTION OF NSK PRIMADO2 SLIM MOTOR, P200-SMH. DETAILS ARE AS FOLLOWS. ON (B)(6) 2015, A DOCTOR WAS PERFORMING AN OPERATION. THE MOTOR DID NOT WORK AT ALL FROM THE BEGINNING OF THE OPERATION. THERE WAS NO DELAY ON THE OPERATION DUE TO THE MALFUNCTION. ACCORDING TO THE HOSPITAL, THE MOTOR ALSO MALFUNCTIONED ON (B)(6) 2015. ON (B)(6) 2015, THE MOTOR WAS SITTING ON THE TABLE IN AN OPERATION ROOM, AND SUDDENLY STARTED WORKING WITHOUT PRESSING THE FOOTPEDAL, THEN STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813322 NSK MOTOR, DRILL, ELECTRIC HBC NAKANISHI INC. P200-SMH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other