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

Model Number TI-MAX X600KL

Device Problems Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907); Misassembly by Users (3133); Device Fell (4014)

Patient Problems Chemical Exposure (2570); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

Nakanishi is currently trying to obtain further information about the event, including information about the patient.

Event Description

On july 26, 2019, 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) 2019.A dentist was performing a dental procedure on a patient using the ti-max x600kl handpiece (serial no.: (b)(4)).About 10 minutes after the start of the procedure, the bur mounted in the handpiece suddenly broke and fell in the patient's mouth, and the patient swallowed the broken bur.The bur had been mounted by the dental nurse, who had checked that the bur was well tightened.The patient was hospitalized to get a gastroscopy exam.

Manufacturer Narrative

Nakanishi received information about the patient from the distributor.The patient's weight, ethnicity, and race were not included; the dentist refused to provide the information.

Manufacturer Narrative

Upon receiving the device involved in the mdr event from the distributor, nakanishi tried to conduct a failure analysis of the returned device.However, nakanishi determined that a counterfeit cartridge was incorporated in the handpiece based on the following reasons.- the serial no.On the cartridge did not follow the nsk numbering standard.- the shape of the bearing in the cartridge was different from the original nsk bearing.Therefore, nakanishi was not able to conduct the failure analysis of the device involved in the event.In order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: 1) nakanishi reviewed the operation manual and reconfirmed the warning not to disassemble nor tamper with the device.2) nakanishi reported the above evaluation results to nsk europe and directed nsk europe to remind the user of the importance of using the device as instructed in the operation manual.

• Brand Name: NSK
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, 322-8 666; JA 322-8666
• MDR Report Key: 8904974
• MDR Text Key: 159021850
• Report Number: 9611253-2019-00039
• 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,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TI-MAX X600KL
• Device Catalogue Number: P858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR