BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK

    MDR report key: 6095368 · Received November 11, 2016

    Report

    Report Number
    9611253-2016-00066
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 18, 2016
    Report Date
    March 14, 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: A) NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT P200-SMH-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 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 ERROR MESSAGE "E03" HAD APPEARED ON THE MONITOR OF THE UNIT WHEN GRASPING THE HANDSWITCH. HOWEVER, THE MOTOR DID NOT ACTIVATED. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENT(S) INVOLVED: NAKANISHI DISASSEMBLED THE DEVICE AND PERFORMED A VISUAL INSPECTION OF THE INSIDE PARTS. NAKANISHI OBSERVED: - A MARK OF RESIDUAL WATER IN THE ARMATURE. - CORROSION ON THE SURFACE OF THE ARMATURE. - WATER ON THE CONNECTOR BETWEEN THE ARMATURE AND THE CORD. - SIGNS OF SHORT CIRCUIT BETWEEN VCC AND V1 ON THE P.C.BOARD DUE TO WATER INGRESS. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: 1) NAKANISHI IDENTIFIED FROM SIGNS/MARKS OBSERVED IN THE ABOVE VISUAL INSPECTION, THAT THE CAUSE OF THE MALFUNCTION OF THE RETURNED DEVICE WAS SHORT CIRCUIT OF THE P.C.BOARD DUE TO WATER INGRESS INTO THE INSIDE PARTS. 2) ACCORDING TO THE HOSPITAL, THE DOCTOR WASHED THE DEVICE BY A HIGH-TEMPERATURE CLEANING METHOD, WHICH NAKANISHI DOES NOT RECOMMEND AS A PROPER CLEANING METHOD FOR THE DEVICE. 3) ERRONEOUS MAINTENANCE BY THE USER CAUSES SHORT CIRCUIT OF THE P.C.BOARD, WHICH CONTRIBUTES TO THE REPORTED MALFUNCTION. 4) IN ORDER TO PREVENT A RECURRENCE OF THE HANDSWITCH MALFUNCTION, NAKANISHI TOOK THE FOLLOWING ACTIONS: 4.1) NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. 4.2) NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO THE DOCTOR AND DIRECTED THE DOCTOR TO WASH THE DEVICE BY THE CLEANING METHOD DESCRIBED IN THE OPERATION MANUAL.

    Description of Event or Problem · 1

    ON (B)(6) 2016, NAKANISHI RECEIVED A PHONE CALL FROM A DISTRIBUTOR ABOUT A MALFUNCTION OF AN NSK SURGICAL DEVICE. DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2016. THE PRIMADO2 P200-SMH-HS MOTOR SUDDENLY ACTIVATED WHILE THE HANDSWITCH WAS IN THE OFF POSITION ON THE TABLE. SINCE THE PROBLEM DID NOT HAPPEN PRIOR TO/DURING AN OPERATION, THERE WAS NO PATIENT INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748100 NSK MOTOR, DRILL, ELECTRIC HBC NAKANISHI INC. P200-SMH-HS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other