MAUDE Adverse Event Report: NAKANISHI INC. FORZA F5; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Model Number FORZA F5

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 01/18/2019

Event Type  Injury  

Manufacturer Narrative

Nakanishi is still trying to obtain further information about the event.

Event Description

On (b)(6) 2019, nakanishi received an e-mail from a distributor (b)(4) stating that a patient had submitted an mdr report (report no.#mw5083723) to fda about an nsk handpiece overheating.The details of the event were as follows.The event occurred on (b)(6) 2019.A dentist was performing a dental procedure using the forza f5 handpiece (serial no.: unknown).During the procedure, the handpiece overheated and burned the patient's tongue severely.The patient reported that the burn was so severe that the injury was still not healed.The patient suffered extreme pain from the burn, and could not eat, sleep and talk for about 7 days.

Manufacturer Narrative

On january 10, 2020, nakanishi sent an email to the distributor requesting details about the event.On january 11, 2019, nakanishi received a response stating that the dentist had refused to provide any further information, including information about the patient and the device.According to the distributor, the dentist also refused to return the device involved in the event.

• Brand Name: FORZA F5
• 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: 8520772
• MDR Text Key: 142196339
• Report Number: 9611253-2019-00026
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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: Health Professional
• Device Model Number: FORZA F5
• Device Catalogue Number: 5021285U0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 01/11/2020
• Supplement Dates FDA Received: 02/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other