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Model Number SGS-E2S |
Device Problems
Nonstandard Device (1420); Overheating of Device (1437)
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Patient Problems
Burn(s) (1757); Superficial (First Degree) Burn (2685)
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Event Date 08/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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The dentist refused to provide the patient's weight, ethnicity, and race.The same adverse event in this report has been reported to the fda separately by the distributor, (b)(4), under report number (b)(4).
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Event Description
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On september 30, 2021, nakanishi became aware of a handpiece overheating through a complaint input into the complaint database by a distributor ((b)(4)).According to the distributor, there are two devices suspected to be involved in the event, but the dentist could not identify which one of the devices actually caused the following event.Therefore, nakanishi is submitting two separate mdrs for this event.This mdr is regarding the handpiece with the serial number (b)(4).Details are as follows: - the event occurred on (b)(6) 2021.- the dentist was performing a wisdom extraction on the patient using the sgs-e2s handpiece (serial no.(b)(4)).- during the procedure, the device overheated and the patient received a minor burn injury, which had visible redness without blistering, to the exterior portion of their lip.- the injury has healed normally without any additional complications or need for medical treatment.
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Manufacturer Narrative
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Upon receiving the device involved in the mdr event from the distributor, nakanishi conducted a failure analysis of the returned device, which included measuring the operating temperature of the device [report no.(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 sgs-e2s device [serial no.(b)(6)].There were no problems observed during 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 (4)).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 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 (80,000 min-1 for the handpiece), with no water spray, and measured the exothermic response.Nakanishi measured the temperature rise of the returned handpiece set at 80,000 min-1 (motor revolution 40,000 min-1).Nakanishi observed an abnormal temperature rise at all of the test points a few seconds into the test.Temperature measurements 5 minutes after the start of the test were as follows: test point (1): 65.1 degrees c, test point (2): 58.5 degrees c, test point (3): 58.1 degrees c, test point (4): 64.8 degrees c.Identification of the specific failure mode(s) and/or mechanism(s) of the associated device components was conducted as follows: nakanishi disassembled the handpiece and performed a visual inspection of the internal parts.Nakanishi observed that the bearing was soiled and discolored.Nakanishi took photographs of all the disassembled parts and kept them in investigation report no.(b)(4).Conclusions reached based on the investigation and analysis results: nakanishi determined that the cause of the overheating of the returned device was abnormal resistance during rotation due to the soiled bearing.Nakanishi considers the possibility from many years of experience that the cause of the soiled bearing was the ingress of undesirable materials into the bearing, leading to abrasion.A lack of maintenance caused the accumulation of debris on the internal parts, which caused debris ingress into the bearing during rotation.This contributed 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 nsk america and directed nsk america to remind the user of the importance of maintenance, as instructed in the operation manual.
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Search Alerts/Recalls
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