BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK

    MDR report key: 6725560 · Received July 19, 2017

    Report

    Report Number
    9611253-2017-00035
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    June 25, 2017
    Report Date
    August 3, 2017
    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

    UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT FROM A DISTRIBUTOR, 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 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. NAKANISHI CONNECTED THE RETURNED DEVICE TO A COMPANY-OWNED UNIT (P200-CU-100) TO OBSERVE WHETHER OR NOT THE REPORTED PHENOMENON COULD BE REPLICATED. NAKANISHI OBSERVED THAT THE VR1 SIGNAL WAS SWITCHED FROM 2 TO 122 AND THE MOTOR STARTED ROTATING AT 1,000-10,000RPM WHEN THE HANDSWITCH LEVER WAS SIMPLY RAISED. (THE SAFETY LOCK WAS IN THE OFF-STATE). THE VR1 INDICATED 220-280 WHEN SWITCHING THE SAFETY LOCK TO THE ON-STATE. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENT(S) INVOLVED: NAKANISHI SEPARATED THE DEVICE INTO THE ARMATURE SIDE AND THE CORD ASSEMBLY. NAKANISHI THEN, CONNECTED A WELL-FUNCTIONING ARMATURE PART WITH THE RETURNED MOTOR ASSEMBLY AS WELL AS THE RETURNED ARMATURE PART WITH A WELL-FUNCTIONING MOTOR ASSEMBLY, AND PERFORMED THE SAME OPERATION CHECK AS DESCRIBED IN THE ABOVE B). NAKANISHI OBSERVED REPLICATION OF THE REPORTED MALFUNCTION WITH A COMBINATION OF THE RETURNED ARMATURE PART WITH THE WELL-FUNCTIONING MOTOR ASSY. NAKANISHI OBSERVED THE VR1 ON THE ARMATURE SHOWING THE ABNORMAL VALUE, 440, IN THE OPERATION CHECK. HOWEVER, NAKANISHI CONFIRMED THE VR1 WAS BACK TO NORMAL AS SHOWN BELOW IN THE FOLLOWING CONDITIONS. VR1: 530 WHEN PLACING THE MAGNET IN THE HANDSWITCH CLOSE TO THE CHIP, IC1. VR1: 2 WHEN PLACING THE MAGNET IN THE HANDSWITCH CLOSE TO THE CHIP, IC3. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: NAKANISHI IDENTIFIED THAT THE CAUSE OF THE MALFUNCTION OF THE RETURNED DEVICE WAS THE IC1 HAD ERRONEOUSLY DETECTED MAGNETISM. ACCORDING TO THE HOSPITAL, THE VETERINARIAN STERILIZED THE DEVICE USING GAS, WHICH NAKANISHI DOES NOT RECOMMEND AS A PROPER STERILIZATION METHOD FOR THE DEVICE. ERRONEOUS MAINTENANCE BY THE USER CAUSES A DEFECT IN THE CHIPS OF THE ARMATURE, WHICH CONTRIBUTES TO THE REPORTED MALFUNCTION. IN ORDER TO PREVENT A RECURRENCE OF THE HANDSWITCH MALFUNCTION, NAKANISHI TOOK THE FOLLOWING ACTIONS: NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO THE VETERINARIAN AND DIRECTED THE VETERINARIAN TO STERILIZE THE DEVICE BY THE STERILIZATION METHOD DESCRIBED IN THE OPERATION MANUAL.

    Description of Event or Problem · 1

    ON JUNE 26, 2017, NAKANISHI RECEIVED INFORMATION FROM A VETERINARIAN ABOUT A MALFUNCTION OF AN NSK SURGICAL DEVICE. DETAILS ARE AS FOLLOWS. - THE EVENT OCCURRED ON (B)(6) 2017. - WHEN THE VETERINARIAN WAS CHECKING THE PRIMADO2 P200-HMH-HS (SERIAL NO. (B)(4)) PRIOR TO USE, THE MOTOR SUDDENLY ACTIVATED DESPITE THE FACT THE HANDSWITCH WAS IN THE OFF POSITION. - THERE WAS NO PATIENT INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505032 NSK MOTOR, DRILL, ELECTRIC HBC NAKANISHI INC. P200-HMH-HS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other