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

Model Number EX-5 STR

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

No information was provided about the dentist who suffered from the burn injury.(b)(4) is attempting to obtain further information regarding the event and the dentist.

Event Description

On (b)(6) 2020, (b)(4) received an e-mail from a distributor (stryker) about a handpiece overheating.Details are as follows.The event occurred on (b)(6) 2020.The dentist suffered a burn on the skin from the ex-5 str handpiece (serial no.Unknown).

Manufacturer Narrative

On (b)(6) 2021, nakanishi received an email from the distributor stating that the device involved in the event is not expected to be returned to the manufacturer soon because the industry has been restricted from the usual shipping activities for non-essential items during the covid-19 crisis.

• 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: 10177601
• MDR Text Key: 201013372
• Report Number: 9611253-2020-00028
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• PMA/PMN Number: K962540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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: EX-5 STR
• Device Catalogue Number: H161
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other