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

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.

• Brand Name: SOLARA
• Type of Device: HANDPIECE, 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 Key: 12921766
• MDR Text Key: 282705205
• Report Number: 9611253-2021-00068
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• 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 Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SOLARA-03 (GRW)
• Device Catalogue Number: P066019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other