BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK

    MDR report key: 5938803 · Received September 9, 2016

    Report

    Report Number
    9611253-2016-00053
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Date of Event
    August 3, 2016
    Report Date
    January 24, 2017
    Manufacturer
    NAKANISHI INC.
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF SEPTEMBER 5, 2016, NAKANISHI HAS NOT RECEIVED INFORMATION ABOUT PATIENT'S WEIGHT. NAKANISHI WILL ASK FOR THE INFORMATION AT THE NEXT CONTACT. THIS EVENT OCCURRED IN (B)(6), BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K073678.

    Additional Manufacturer Narrative · 1

    ON SEPTEMBER 5, 2016, NAKANISHI RECEIVED THE INFORMATION FROM THE DISTRIBUTOR THAT THE PATIENT HAD NOT BEEN INJURED BY THE EVENT AND THAT THE PATIENT WEIGHT HAD NOT BEEN PROVIDED FROM THE DENTIST. UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT FROM A DISTRIBUTOR, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE [C160819-04-1]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT H-SG1 DEVICE [LOT NUMBER 0F7]. THERE WERE NO PROBLEMS OBSERVED REGARDING MANUFACTURING OR TESTING THAT WERE NOTED IN THE DHR. THERE WERE ALSO NO REPAIR HISTORY RECORDS SINCE THE DEVICE WAS SHIPPED. NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. NAKANISHI OBSERVED THAT THE TIP WAS BROKEN INTO TWO AT THE CURVED PART. NAKANISHI THEN PERFORMED A VISUAL INSPECTION OF THE TIP USING AN ELECTRONIC MICROSCOPE. NAKANISHI OBSERVED: - FATIGUE/DUCTILE FRACTURE ON THE BROKEN SURFACE OF THE TIP. - DEFORMATION/ABRASION ON THE BLADE OF THE TIP. NAKANISHI TOOK PHOTOGRAPHS OF ALL THE DAMAGE ON THE TIP AND KEPT THEM IN A FILE. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS : NAKANISHI IDENTIFIED FROM THE ABOVE OBSERVATION THAT THE CAUSE OF TIP BREAKAGE WAS CUTTING UNDER HIGH LOAD WITH A METALLICALLY-FATIGUED TIP. METAL FATIGUE/DEFORMATION OF THE TIP LED TO DECREASED CUTTING EFFICIENCY, WHICH LED TO BREAKAGE WHEN CUTTING UNDER HIGH LOAD. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE OPERATION MANUAL ABOUT WHEN TO REPLACE THE TIP LED TO THE ABOVE PHENOMENON, WHICH CONTRIBUTED TO THE REPORTED BREAKAGE OF THE TIP. IN ORDER TO PREVENT A RECURRENCE OF THE TIP BREAKAGE, 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 DISTRIBUTOR AND DIRECTED THE DISTRIBUTOR TO REMIND THE USER OF THE IMPORTANCE OF REPLACING THE BUR IN A TIMELY MANNER, AS INSTRUCTED IN THE OPERATION MANUAL.

    Description of Event or Problem · 1

    ON AUGUST 19, 2016, AN NSK VARIOSURG3 TIP, H-SG1 (LOT NO. 0F7) WAS RETURNED FROM A DISTRIBUTOR TO NAKANISHI. THERE WAS A NOTE WITH THE TIP DESCRIBING THE OCCURRENCE OF TIP BREAKAGE. DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2016. A DENTIST WAS CUTTING A BONE FOR EXTRACTION OF A TOOTH OF THE PATIENT'S LOWER LEFT JAW USING THE H-SG1. DURING THE BONE CUTTING, THE TIP SUDDENLY BROKE. THE BREAKAGE OCCURRED ON THE THIRD USE OF THE TIP. NAKANISHI IS STILL INVESTIGATING WHETHER OR NOT THE EVENT POSED A HEALTH HAZARD TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590528 NSK SCALER, ULTRASONIC ELC NAKANISHI INC. H-SG1 0F7

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other