MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, ROTARY BONE CUTTING

Model Number SGA-E2S

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Scarring (2061); Numbness (2415); Partial thickness (Second Degree) Burn (2694)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

According to the distributor, the dentist refused to provide the patient's weight, ethnicity, and race.The same adverse event in this report has been reported to the fda separately by the initial importer, nsk america corporation, under report number (b)(4).

Event Description

On february 6, 2021, nakanishi became aware of a handpiece overheating through a complaint input into the complaint database by a distributor (nsk america).Details are as follows: the event occurred on (b)(6) 2020.A dentist was performing a 3rd molar extraction on the patient using the sga-e2s handpiece (serial no.(b)(4)).The patient was under sedation.During the procedure, the device overheated and burned the patient's mouth and lower lip.The patient is reported to have scarring and is experiencing continued loss of feeling at the site of the injury, which will require further medical treatment.

Manufacturer Narrative

On (b)(6) 2021, nakanishi received an email from the distributor stating that the handpiece involved in the adverse event would not be returned to the manufacturer for investigation because the user had the device repaired by a third party after the event and the device was no longer in the original failed condition.

• Brand Name: NSK
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 11402613
• MDR Text Key: 242662171
• Report Number: 9611253-2021-00013
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• PMA/PMN Number: K171155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGA-E2S
• Device Catalogue Number: H265
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR