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Model Number Z800KL |
Device Problems
Detachment of Device or Device Component (2907); Misassembly by Users (3133)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2024 |
Event Type
Injury
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Event Description
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On february 23, 2024, nakanishi became aware of a patient's accidental ingestion of a dental bur through a complaint input into the complaint database by a distributor (nsk america).Details are as follows: the event occurred on january 9, 2024.A dentist was performing a restorative filling preparation on the patient's teeth #22, 23 and 24 using the z800kl handpiece (serial no.(b)(6)).During the procedure, the bur came out unexpectedly and landed on the dorsal side of the patient's tongue, and the patient swallowed the bur.The dentist has had a follow up visit with the patient and is expected to have passed the bur without complication.
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Manufacturer Narrative
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The same adverse event in this report has been reported to the fda separately by the distributor, (b)(4), under report number 1422375-2024-00005.
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Manufacturer Narrative
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Upon receiving an email from the distributor (nsk america) stating that the distributor found that a counterfeit cartridge was incorporated in the handpiece involved in the adverse event and showing photos of the handpiece with the counterfeit cartridge, nakanishi reviewed the photos of the handpiece with the counterfeit cartridge which the distributor took and determined that the cartridge mounted to the handpiece was counterfeit based on the following reasons.The shape of the button and screw in the cartridge were different from the original nsk's cartridge.The shape of the dustproof disk in the cartridge was different from the original nsk's cartridge.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 bur separation, 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 will report the above evaluation results to the distributor and directed the distributor 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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