BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK

    MDR report key: 5663077 · Received May 18, 2016

    Report

    Report Number
    9611253-2016-00024
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    April 21, 2016
    Report Date
    November 2, 2016
    Manufacturer
    NAKANISHI INC.
    Product Code
    HBC
    PMA / PMN Number
    K132264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF MAY 16, 2016, NAKANISHI IS STILL GATHERING INFORMATION ABOUT THE PATIENT. THIS EVENT IS ABOUT THE MEDICAL DEVICE FOR ANIMALS, BUT THE SAME PRODUCT IS MARKETED IN THE US FOR HUMAN BEING.

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT FROM A DISTRIBUTOR, (B)(4) CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: A) NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT P200-HMH-HS DEVICE [SERIAL NUMBER (B)(4)]. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. THERE WERE ALSO NO REPAIR HISTORY RECORDS SINCE THE DEVICE WAS SHIPPED. B) NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE AND OBSERVED NO VISIBLE ABNORMALITIES, SUCH AS CRACKS OR DEBRIS, ON THE OUTSIDE OF THE MOTOR. C) NAKANISHI CONNECTED THE RETURNED DEVICE TO A COMPANY-OWNED UNIT (P200-CU-100) FOR OPERATION CHECK. NAKANISHI OBSERVED THAT THE MOTOR STARTED ROTATING BY ITSELF WITHOUT RELEASING THE SAFETY LOCK. D) AN HOUR LATER, NAKANISHI RECONNECTED THE MOTOR TO THE UNIT TO PERFORM THE OPERATION CHECK AGAIN. THIS TIME, THE MOTOR ROTATION REACHED THE MAXIMUM SPEED, RIGHT AFTER SWITCHING THE SAFETY LOCK FROM OFF-STATE TO THE ON-STATE. E) NAKANISHI MEASURED THE RESISTANCE OF THE RETURNED DEVICE AT VARIOUS POINTS BY CONNECTING TO THE MOTOR OUTPUT ASSY. NAKANISHI FOUND NO SIGNIFICANT DIFFERENCE OF THE RESISTANCE VALUES BETWEEN WHAT WAS CONFIRMED IN THE RESISTANCE MEASUREMENT AND THE ONES OF A BRAND-NEW PRODUCT. F) NAKANISHI REMOVED THE ARMATURE FROM THE MOTOR CASE AND MEASURED VR1 IN THE FOLLOWING COMBINATIONS. (NOTE) VR: THE AMOUNT OF SIGNAL TRANSMITTED FROM THE MOTOR HANDSWITCH TO THE UNIT OUTPUT ASSY. WHEN THE AMOUNT EXCEEDS A CERTAIN LEVEL, THE MOTOR IS ACTIVATED. THE RESULTS ARE: - COMBINATION OF RETURNED ARMATURE AND NEW CORD ASSY -> VR1: 423 (ABNORMAL). - COMBINATION OF NEW ARMATURE AND RETURNED CORD ASSY -> VR1: 1 (NORMAL). IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENT(S) INVOLVED: A) NAKANISHI DISASSEMBLED THE DEVICE AND PERFORMED A VISUAL INSPECTION OF THE INSIDE PARTS. NAKANISHI OBSERVED THE FOLLOWING PHENOMENA: - A PART OF SILICON REMOVED FROM THE H.S.BOARD. - COATING REMOVED FROM THE LEAD WIRE. B) NAKANISHI REMOVED THE SILICON FROM THE H.S.BOARD AND CHECKED ALL THE ELEMENTS MOUNTED ON THE H.S.BOARD. WHEN MEASURING THE VR AFTER REMOVING THE CHIP "R6" AND SOLDER-REMOUNTING THE CHIP FIRMLY ON THE H.S.BOARD, NAKANISHI CONFIRMED THE VR VALUE BACK TO NORMAL. THIS INDICATES CONTACT FAILURE OF THE R6 WITH THE H.S.BOARD. C) THEN, NAKANISHI PREPARED A NORMALLY OPERATING P200-HMH-HS, AND REMOVED THE R6 FROM THE P200-HMH-HS H.S.BOARD, AND MEASURED THE VR WITHOUT THE CHIP. THE RESULT WAS OUTSIDE OF THE REFERENCE VALUES. D) NAKANISHI ASKED THE R6 MANUFACTURER, ROHM CO., LTD. FOR FURTHER ANALYSIS OF THE CHIP. ACCORDING TO THE ANALYSIS RESULTS, THE CHIP SHOWS SIGNS OF SULFURIZATION. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: NAKANISHI IDENTIFIED THAT THE CAUSE OF THE MALFUNCTION OF THE RETURNED DEVICE WAS THE CHIPS NOT BEING PROPERLY SOLDER-MOUNTED ON THE H.S.BOARD, WHICH CONTRIBUTED TO ERRONEOUS MOTION OF THE CIRCUIT BOARD. NAKANISHI CONSIDERS THE POSSIBILITY FROM MANY YEARS OF EXPERIENCE THAT THE CAUSE OF THE LOOSENED R6 IS DUE TO THE MANUFACTURING PROCESS. IN THE MANUFACTURING PROCESS, NAKANISHI SEPARATES A H.S.BOARD PLATE INTO PIECES BY BREAKING THE PLATE WITH HUMAN HANDS. IN THE SEPARATING PROCESS, THE R6 SOLDER-MOUNTED ON THE H.S.BOARD MAY BECOME UNSTABLE, WHICH CAUSES THE ABOVE PHENOMENA. IN ORDER TO PREVENT A RECURRENCE OF THE HANDSWITCH MALFUNCTION, NAKANISHI REVIEWED AND CHANGED MANUFACTURING PROCESS FROM SEPARATING THE H.S.BOARD WITH HANDS TO USING A SEPARATING INSTRUMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, AN NSK SURGICAL DEVICE, P200-HMH-HS (SERIAL NO. (B)(4)) WAS RETURNED FROM A DISTRIBUTOR TO NAKANISHI FOR REPAIR. THERE WAS A NOTE INCLUDED WITH THE DEVICE STATING THAT THE DEVICE HAD MALFUNCTIONED DURING AN OPERATION. THE DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2016. THE DOCTOR WAS PERFORMING THE DISK HERNIA OPERATION ON AN ANIMAL PATIENT (DOG). SUDDENLY, THE MOTOR ACTIVATED, WHEN THE HANDSWITCH WAS IN THE OFF-STATE. THE MALFUNCTION DID NOT AFFECT THE OPERATION SUCH AS DELAY IN OPERATION, ETC., BECAUSE IT'S ONLY A TEMPORARY PHENOMENON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319903 NSK MOTOR, DRILL, ELECTRIC HBC NAKANISHI INC. P200-HMH-HS

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other