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

Model Number TI-MAX X500KL

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Nakanishi is now trying to obtain further information about the event including the patient information.

Event Description

On october 25, 2018, nakanishi received an e-mail 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) 2018.The dentist was performing dental restorations on a patient using the ti-max x500kl handpiece (serial no.(b)(4)).During the procedure, the bur attached to the handpiece suddenly came out and the patient swallowed the bur.The patient was sent to a hospital to get chest x-rays.

Event Description

On june 11, 2019, nakanishi received additional information on the event from the distributor.- the procedure the dentist was performing at the time of the event was removal of carious lesion.- the patient was under anesthesia (mild sedation with nitrous oxide).- the chest x-rays found that the bur did not enter the patient's lung.- the dentist has followed up with the patient and determined that there was no further medical treatment required.

Manufacturer Narrative

According to the distributor, the dentist refused to provide the patient's id and weight.Due to the device not being returned from the distributor, nakanishi inc., japan (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.

• Brand Name: NSK
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 8102341
• MDR Text Key: 128399471
• Report Number: 9611253-2018-00057
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K113655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/25/2018,07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TI-MAX X500KL
• Device Catalogue Number: P857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2018
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/25/2018
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR