Nakanishi could not obtain information about the patient's identifier, age and weight in the conversation with the dentist.Nakanishi will try again to collect the information in the next communication.This event occurred in (b)(6), but similar products are marketed in the us under k972569.
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On may 21, 2018, an nsk handpiece z84l was returned from a dealer to nakanishi for repair.There was a note with the device stating that the device had burned a patient.Upon receipt of the information, nakanishi made a phone call to the dentist for further information about the event.The details nakanishi obtained from the communication are as follows.- the event occurred in (b)(6) 2018.- the dentist was forming a patient's tooth using the handpiece z84l (serial no.(b)(4)).- the patient was not under anesthesia.- during the procedure, the dentist found a one-centimeter burn injury in the patient's mouth.
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On june 6, 2018, nakanishi made a phone call to the dentist for information about the patient.The dentist refused to provide the information.Upon receiving the device involved in the mdr event from a dealer, nakanishi conducted a failure analysis of the returned device that included measuring the operating temperature of the device (b)(4).These activities are described in more detail below.Methodology used: nakanishi examined the device history record and the repair history for the subject z84l 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 conducted temperature testing of the returned device in the following manner: temperature sensors were attached to the exterior of the device at various test points.This included the point most proximal to the patient (testing point (1)) and points further toward the distal end of the device (testing points (2) through (3)).The test setup was prepared to take temperature measurements at all points simultaneously, including a reference measurement at ambient room temperature.Nakanishi attached a thermocouple (sensor to measure a temperature) to each of the testing points.Nakanishi rotated the device's motor at 40,000 min-1, which is the maximum rpm for the motor that drives the handpiece (180,000 min-1 for the handpiece), with water spray, and measured the exothermic response.Nakanishi measured the temperature rise of the returned handpiece set at 180,000 min-1 (motor revolution 40,000 min-1).Nakanishi observed an abnormal temperature rise at test point (2) a few seconds after the start.Temperature measurements 148 seconds after the start are as follows: test point (1): 46.4 degrees c; test point (2): 63.0 degrees c; test point (3): 31.6 degrees c.The rise in temperature was so significant that the test was concluded 148 seconds into the planned 5 minute evaluation period.Identification of the specific failure mode(s) and/or mechanism(s) and the associated device components involved: nakanishi disassembled the handpiece and performed a visual inspection of the inside parts.Nakanishi observed that the bearing retainer (ball retaining part) on the cartridge rear side was broken.Nakanishi took photographs of all of the disassembled parts and kept them in the investigation report #(b)(4).Conclusions reached based on the investigation and analysis results: nakanishi identified that the cause of the overheating of the returned device was abnormal resistance during rotation caused by the broken bearing due to the ingress of undesirable materials into the bearing.A lack of maintenance causes the accumulation of debris on the inside parts, which causes debris ingress into the bearing during rotation.This contributes to the handpiece overheating.In order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: nakanishi reviewed the operation manual and reconfirmed the clarity and understandability of the instructions.Nakanishi reported the above evaluation results to the dentist and reminded the dentist of the importance of pre-use checks and maintenance, as instructed in the operation manual.
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