BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK

    MDR report key: 8126651 · Received December 3, 2018

    Report

    Report Number
    9611253-2018-00059
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 18, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    HBC
    PMA / PMN Number
    K132264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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-HMH-HS DEVICE [SERIAL NUMBER 0BC20010]. 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 SET THE ATTACHMENT TO THE RETURNED DEVICE AND CONNECTED THE DEVICE WITH THE ATTACHMENT TO THE CONTROL UNIT (P200-CU-100) TO OBSERVE WHETHER OR NOT THE REPORTED PHENOMENON COULD BE REPLICATED. NAKANISHI OBSERVED NEITHER DEACTIVATION OF THE DEVICE NOR ANY ERROR CODE ON THE DISPLAY PANEL IN THE OPERATION TEST. NAKANISHI THEN REMOVED THE ATTACHMENT FROM THE DEVICE AND CONDUCTED THE SAME OPERATION TEST WITHOUT THE ATTACHMENT. NAKANISHI DID NOT OBSERVE ANY ABNORMALITIES IN THE TEST. C) NAKANISHI PERFORMED HIGH-SPEED STERILIZATION OF THE DEVICE IN A WAY SIMILAR TO THE WAY THE HOSPITAL DID AND CONDUCTED THE OPERATION TEST AS DESCRIBED IN B). NAKANISHI DID NOT OBSERVE ANY ABNORMALITIES IN THIS TEST EITHER. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENT(S) INVOLVED : A) NAKANISHI DISASSEMBLED THE MOTOR AND PERFORMED A VISUAL INSPECTION OF THE INSIDE PARTS. NAKANISHI OBSERVED THE FOLLOWING PHENOMENA: - THERE WAS CORROSION DUE TO WATER INGRESS ON THE CIRCUIT BOARD FOR THE CORD CONNECTOR. - THE BLUE LEAD WIRE TO TRANSMIT SIGNALS TO THE CONTROL UNIT WAS BROKEN, WHICH CAUSES A FAILURE TO LOCATE THE MOTOR, LEADING TO THE DISPLAY OF ERROR CODE "E03". - THERE WAS WHITISH DEBRIS AND CORROSION ON THE OTHER PARTS. B) NAKANISHI TOOK PHOTOGRAPHS OF ALL OF THE DISASSEMBLED PARTS AND KEPT THEM IN THE INVESTIGATION REPORT #181109-08-01. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: 1) NAKANISHI IDENTIFIED THAT THE CAUSE OF THE MALFUNCTION OF THE RETURNED DEVICE WAS A BROKEN LEAD, AS DESCRIBED IN A) ABOVE. 2) PERFORMING HIGH-SPEED STERILIZATION ON THE DEVICE, WHICH NAKANISHI DOES NOT RECOMMEND AS A PROPER STERILIZATION METHOD FOR THE DEVICE, CAUSES CORROSION INSIDE THE MOTOR, WHICH LIKELY LED TO THE BROKEN LEAD. 3) ERRONEOUS MAINTENANCE BY THE USER CONTRIBUTED 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 STERILIZE THE DEVICE BY THE STERILIZATION METHOD RECOMMENDED IN THE OPERATION MANUAL.

    Description of Event or Problem · 1

    ON (B)(6) 2018, NAKANISHI RECEIVED A PHONE CALL FROM A DEALER ABOUT A MALFUNCTION OF AN NSK SURGICAL DEVICE. UPON RECEIPT OF THE INFORMATION, NAKANISHI VISITED THE HOSPITAL FOR FURTHER INFORMATION ABOUT THE EVENT. THE DETAILS NAKANISHI OBTAINED FROM THE COMMUNICATION ARE AS FOLLOWS THE EVENT OCCURRED ON (B)(6) 2018. A DOCTOR WAS PERFORMING A SURGICAL PROCEDURE USING THE PRIMADO2 DEVICE, P200-HMH-HS (SERIAL NO. (B)(4)). ABOUT 15 MINUTES AFTER STARTING THE PROCEDURE, THE MOTOR WAS SUDDENLY DEACTIVATED WITH THE ERROR CODE "E03", DESPITE THE FACT THE HANDSWITCH WAS IN THE ON POSITION. NO OVERHEATING WAS OBSERVED. THE DOCTOR CONNECTED ANOTHER P200-HMH-HS (SERIAL NO. (B)(4)) TO THE CONTROL UNIT AFTER STERILIZING THE DEVICE AT 132 DEGREES C FOR 10 MINUTES. THE DEVICE, P200-HMH-HS (SERIAL NO. (B)(4)) ALSO DID NOT ACTIVATE WITH THE CODE "E03" EVEN IN THE ON POSITION. AFTER A PERIOD OF TIME, THE ERROR CODE OF THE SECOND DEVICE DISAPPEARED AND THE DEVICE STARTED ROTATING. THERE WAS NO HEALTH DAMAGE CAUSED TO THE PATIENT IN THE EVENT. NAKANISHI IS SUBMITTING TWO SEPARATE MDRS FOR THIS EVENT DUE TO 2 DEVICES INVOLVED IN THE EVENT. THIS MDR IS REGARDING THE DEVICE WITH THE SERIAL NUMBER (B)(4). THE OTHER DEVICE IS BEING REPORTED AS #9611253-2018-00062.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962993 NSK MOTOR, DRILL, ELECTRIC HBC NAKANISHI INC. P200-HMH-HS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other