Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. SGA-E2S; DENTAL HANDPIECE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NAKANISHI INC. SGA-E2S; DENTAL HANDPIECE Back to Search Results
Model Number SGA-E2S
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code Partial thickness (Second Degree) Burn (2694)
Date of Event 05/19/2026
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor had their sga-e2s handpiece overheat unexpectedly during a third molar extraction and the patient received a thermal burn injury to their lip.The patient's injury was treated at the time of the incident without need for additional treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SGA-E2S
Common Device Name
DENTAL HANDPIECE
Manufacturer (Section D)
NAKANISHI INC.
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA  322-8666
MDR Report Key25739979
Report Number1422375-2026-00026
Device Sequence Number10645484
Product Code KMW
UDI-Device Identifier04560264556287
UDI-Public04560264556287
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 07/07/2026
Report Date (Section F) 06/22/2026
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
Operator of Device Health Professional
Device Model NumberSGA-E2S
Device Catalogue NumberH265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2026
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/09/2026
Device Age3 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer06/22/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/07/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
-
-