Model Number PHATELUS 45 TU |
Device Problems
Detachment Of Device Component (1104); Component Falling (1105); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
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Patient Problems
Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
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Event Date 02/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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Nakanishi has not received any information about the patient from the distributor.Nakanishi will continue to obtain the information.
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Event Description
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On march 21, 2017, nakanishi received an e-mail from a distributor ((b)(4)) about a problem with an nsk handpiece.Details are as follows.- the date when the event occurred is unknown.- the bur was tested and there was no fault found.- a dentist was providing a dental treatment for a patient using phatelus 45 tu (serial no.(b)(4)).- during the procedure, the bur installed in the handpiece came off and the patient swallowed the bur.- the bur was not recovered.
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Manufacturer Narrative
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When nakanishi obtained the detailed information on the event from (b)(4) on (b)(6) 2017, the patient information was not included.According to the distributor, the dentist refused to provide the information.On (b)(6) 2017, nakanishi received a phone call from the distributor saying that the device involved in the event would not be returned.Due to the device not being returned from the distributor, nakanishi inc., (b)(4)(manufacturer) made the dhr examination as the investigation approach.As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.
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Event Description
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On april 20, 2017, nakanishi received detailed information on the event.The event occurred on (b)(6) 2017.The procedure the dentist was performing at the time of the event was a molar extraction.The patient was under local anesthesia.After the patient swallowed the bur, the patient was x-rayed and the doctor determined that the bur had been naturally eliminated from the patient's body and no additional treatment was necessary.
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Search Alerts/Recalls
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