MAUDE Adverse Event Report: NAKANISHI INC. NSK; UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Nam took the following actions to obtain further information about the event including the patient, however, no additional information was provided.After the communication with the dental assistant on (b)(6), nam forwarded the information request forms, (b)(4) and (b)(4) to the office by e-mail.No information was provided.On (b)(6) 2018, nam contacted the assistant by e-mail, but no response was received.On (b)(6) 2018, nam sent an e-mail to the assistant requesting to forward all 7 handpieces to nam to avoid a possible event from occurring.No response was received from the dental office.On (b)(6) 2018, nam contacted the assistant by e-mail and voice mail message to request information on the device(s) and the patient.No response was provided.On (b)(6) 2018, nam made a call to the facility requesting identification of the device model number and/or serial number of the device(s).The assistant nor the dentist was available.No response was received.On (b)(6) 2018, nam made a phone call and left a message for the assistant or the dentist to contact nam.No reply was received.On (b)(6) 2018, nam contacted the assistant by email and voice mail requesting information of the device(s) and patient.No information was provided.

Event Description

On (b)(6) 2018, (b)(4) received an e-mail from a distributor (b)(4) about a problem with an (b)(4) dental product.On (b)(6) 2018, (b)(4) was made aware by a phone call from a dental assistant that a dental bur had come out of an (b)(4) handpiece and a patient had swallowed the bur.The event occurred on (b)(6) 2018.The dentist was performing a dental procedure using the handpiece with the bur.During the procedure, the bur came out of the handpiece and the patient swallowed the bur.According to the dental assistant, the patient was not injured in the event.The dentist could not identify the handpiece involved in the event, because the office has 7 handpieces and the subject device was added back into the production rotation of 7 at the time of the event.

• Brand Name: NSK
• Type of Device: UNKNOWN
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer (Section G): NAKANISHI INC. REGISTRATION NUMBER : 9611253; mfr rpt# : 9611253-2018-00012; 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: 7368731
• MDR Text Key: 103545092
• Report Number: 9611253-2018-00012
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/07/2018,03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2018
• Event Location: Other
• Date Report to Manufacturer: 03/07/2018
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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