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Model Number SGA-E2S |
Device Problems
Nonstandard Device (1420); Overheating of Device (1437); Temperature Problem (3022)
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Patient Problems
Burn(s) (1757); Injury (2348); Burn, Thermal (2530)
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Event Date 07/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Nakanishi is currently trying to obtain further information about the event and patient.
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Event Description
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On (b)(6) 2018, nakanishi received an e-mail from a distributor (b)(4) about a handpiece overheating.According to (b)(4), the information was provided through the adverse event questionnaire about the sgs/sga handpieces as a part of recall activities for those devices.The details are as follows.The event occurred in (b)(6) 2015.(the exact date is unknown).A dentist was performing a dental procedure using the sga-e2s handpiece (serial no.Unknown).During the procedure, the handpiece overheated and burned a patient's lip.
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Manufacturer Narrative
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Nsk america (nam) took the following actions, but further information about the event and patient was not provided from the dentist.- on december 14, 2018, nam made a phone call to the dental office.- on january 29, 2019, nam sent an e-mail to the dentist.- on may 28, 2019, nam sent another e-mail to the dentist.
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Manufacturer Narrative
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On july 20, 2019, nakanishi was informed by the distributor (nam) that nam had taken the following actions as a part of the ifu recall activities.On october 15, 2018, nam sent the updated operation manuals that contain the detailed reprocessing method to the dental office to prevent the devices from overheating.On october 22, 2018, nam confirmed the receipt of the operation manuals by the dentist through usps certified receipt.
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Search Alerts/Recalls
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