MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Model Number Z95L

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Injury (2348); Burn, Thermal (2530); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the distributor, the dentist refused to provide the patient's weight, ethnicity and race.

Event Description

On march 12, 2019, nakanishi received an e-mail from a distributor ((b)(4)) about a handpiece overheating.Details are as follows.The event occurred on (b)(6) 2019.The dentist was performing a filling on molars #18 and #19 of the patient's lower jaw using the z95l handpiece (serial no.(b)(4)).The patient was under profound mandibular block anesthesia.During the procedure, the dentist noticed blisters on the patient's cheek and tongue.According to the dentist, there were no abnormalities in the device observed prior to use.As of march 12, 2019, the status of the patient's injury was unknown, because the patient refused to allow the dentist to conduct a follow up visit and has taken his patient record from the office.The dentist reported that there would be further medical attention necessary to treat the burn, but the patient has refused further care from the dentist.

Manufacturer Narrative

On february 21, 2020, nakanishi received an e-mail from (b)(4) containing additional information.Per the e-mail, (b)(4) communicated with the dentist over the phone to request the return of the device for investigation on march 12, 2019.The insurance carrier advised the dentist to retain the handpiece as possible evidence, so the request was refused.Due to the device not being returned from the distributor, nakanishi conducted an investigation by performing a dhr review.The review indicated that no problems occurred during manufacturing or testing of the subject device.

• Brand Name: NSK
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 8471568
• MDR Text Key: 140597981
• Report Number: 9611253-2019-00019
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• PMA/PMN Number: K972569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/12/2019,03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z95L
• Device Catalogue Number: C1034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2019
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/12/2019
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR