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

Model Number SGA-E2S

Device Problems Nonstandard Device (1420); Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/07/2018

Event Type  Injury  

Event Description

On (b)(6), 2022, 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), 2018.The dentist was performing a surgical extraction on a patient using the sga-e2s handpiece (serial no.Unknown).During the procedure, the handpiece overheated and burned the patient.

Manufacturer Narrative

Nakanishi is still trying to obtain detailed information about the event, including information about the patient.Nakanishi will submit a follow-up report to fda when the information is available.

Manufacturer Narrative

The same adverse event in this report has been reported to the fda separately by the distributor, nsk america corporation, under report number (b)(4).

• 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
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; 2245128921
• MDR Report Key: 13677867
• MDR Text Key: 289731520
• Report Number: 9611253-2022-00012
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other