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

Model Number PHATELUS 45 TU

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

Nakanishi has not received any information about the patient from the distributor.Nakanishi will continue to obtain the information.

Event Description

On march 21, 2017, nakanishi received an e-mail from a distributor ((b)(4)) about a problem with an nsk handpiece.Details are as follows.- the date when the event occurred is unknown.- the bur was tested and there was no fault found.- a dentist was providing a dental treatment for a patient using phatelus 45 tu (serial no.(b)(4)).- during the procedure, the bur installed in the handpiece came off and the patient swallowed the bur.- the bur was not recovered.

Manufacturer Narrative

When nakanishi obtained the detailed information on the event from (b)(4) on (b)(6) 2017, the patient information was not included.According to the distributor, the dentist refused to provide the information.On (b)(6) 2017, nakanishi received a phone call from the distributor saying that the device involved in the event would not be returned.Due to the device not being returned from the distributor, nakanishi inc., (b)(4)(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.

Event Description

On april 20, 2017, nakanishi received detailed information on the event.The event occurred on (b)(6) 2017.The procedure the dentist was performing at the time of the event was a molar extraction.The patient was under local anesthesia.After the patient swallowed the bur, the patient was x-rayed and the doctor determined that the bur had been naturally eliminated from the patient's body and no additional treatment was necessary.

• 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
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: kenneth block ; 1201 richardson dr.; suite 160; richardson, TX 75080 ; 9724809554
• MDR Report Key: 6494003
• MDR Text Key: 72840619
• Report Number: 9611253-2017-00016
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: PHATELUS 45 TU
• Device Catalogue Number: P639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: 04/20/2017
• Supplement Dates FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2008
• 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