Model Number TI-MAX X600KL |
Device Problems
Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907); Misassembly by Users (3133); Device Fell (4014)
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Patient Problems
Chemical Exposure (2570); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
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Event Date 07/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Nakanishi is currently trying to obtain further information about the event, including information about the patient.
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Event Description
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On july 26, 2019, nakanishi received an e-mail 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) 2019.A dentist was performing a dental procedure on a patient using the ti-max x600kl handpiece (serial no.: (b)(4)).About 10 minutes after the start of the procedure, the bur mounted in the handpiece suddenly broke and fell in the patient's mouth, and the patient swallowed the broken bur.The bur had been mounted by the dental nurse, who had checked that the bur was well tightened.The patient was hospitalized to get a gastroscopy exam.
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Manufacturer Narrative
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Nakanishi received information about the patient from the distributor.The patient's weight, ethnicity, and race were not included; the dentist refused to provide the information.
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Manufacturer Narrative
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Upon receiving the device involved in the mdr event from the distributor, nakanishi tried to conduct a failure analysis of the returned device.However, nakanishi determined that a counterfeit cartridge was incorporated in the handpiece based on the following reasons.- the serial no.On the cartridge did not follow the nsk numbering standard.- the shape of the bearing in the cartridge was different from the original nsk bearing.Therefore, nakanishi was not able to conduct the failure analysis of the device involved in the event.In order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: 1) nakanishi reviewed the operation manual and reconfirmed the warning not to disassemble nor tamper with the device.2) nakanishi reported the above evaluation results to nsk europe and directed nsk europe to remind the user of the importance of using the device as instructed in the operation manual.
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Search Alerts/Recalls
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