MAUDE Adverse Event Report: NAKANISHI INC. NL9000S; HANDPIECE, AIR-POWERED, DENTAL

Model Number NL9000S

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Slipped (1584); Detachment of Device or Device Component (2907)

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

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

Nakanishi tried to obtain further information about the patient and the event in the communication with the distributor on (b)(6) 2018 and (b)(6) 2018.According to the distributor, despite of the repeated attempts to contact the dentist, the dentist did not disclose the information.

Event Description

On (b)(6), 2018, nakanishi received an email from a distributor (b)(4) about a problem with an nsk dental handpiece.Details are as follows.The event occurred on (b)(6) 2018.A dentist was performing a dental procedure using the nl9000s (serial no.(b)(4)).During the procedure, a bur slipped out of the handpiece and the patient swallowed the bur.

Manufacturer Narrative

On (b)(6) 2018, (b)(6) received an e-mail from the distributor stating that since the device involved in the event had been locally repaired and returned to the dentist, the device was not available for investigation.Due to the device not being returned from the distributor, (b)(6).,(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.

• Brand Name: NL9000S
• 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: 7506411
• MDR Text Key: 108086269
• Report Number: 9611253-2018-00019
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

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?: Yes
• Device Operator: Dentist
• Device Model Number: NL9000S
• Device Catalogue Number: 5021262U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 06/02/2018
• Supplement Dates FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• 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