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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. SOLARA HANDPIECE, AIR-POWERED, DENTAL

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NAKANISHI INC. SOLARA HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Model Number SOLARA-03 (GRW)
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/28/2021
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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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Brand NameSOLARA
Type of DeviceHANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
NAKANISHI INC.
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
Manufacturer (Section G)
NAKANISHI INC.
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
Manufacturer Contact
kenneth block
800 e campbell rd.
suite 202
richardson, TX 75081
9724809554
MDR Report Key12921766
MDR Text Key282705205
Report Number9611253-2021-00068
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSOLARA-03 (GRW)
Device Catalogue NumberP066019
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/02/2021 Patient Sequence Number: 1
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