On december 1, 2021, nakanishi received an email from the distributor stating that the distributor had no intention of returning the device involved in the event or disclosing any further information, including information about the patient.Due to the device not being returned from the distributor, nakanishi examined the device history record (dhr) for the subject solara-03 (grw) device [serial no.(b)(4)].As a result of the examination, nakanishi found that the dhr indicated that no problems occurred during manufacturing and testing of the subject device.
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On november 9, 2021, nakanishi received a letter from a distributor ((b)(4)) about a patient's accidental ingestion of a dental bur.Details are as follows.The event occurred on (b)(6) 2021.The dentist was cutting #14 of the patient's teeth using a turbine handpiece with a built-in nsk cartridge.(serial no.: (b)(4)).During the procedure, the bur fell in the patient's mouth and the patient accidentally swallowed the bur.
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