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. NSK; 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. NSK; DENTAL HANDPIECE Back to Search Results
Model Number SGS-E2S
Device Problem Overheating of Device (1437)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 08/27/2021
Event Type  Injury  
Event Description
Handpiece overheated during a wisdom tooth extraction procedure and patient received a minor burn injury to the exterior portion of their lip.The burn had visible redness without blistering.The injury has healed normally without any additional complications or need for medical treatment.Doctor was unable to identify the specific device involved in the adverse event but was able to identify two possible devices.This report is for one device involved and a second report will be made for the other device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NSK
Type of Device
DENTAL HANDPIECE
Manufacturer (Section D)
NAKANISHI INC.
700 shimohinata
kanuma, tochigi 322-8 666
JA  322-8666
MDR Report Key12585151
MDR Text Key275012091
Report Number1422375-2021-00025
Device Sequence Number1
Product Code KMW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Dentist
Type of Report Initial
Report Date 09/29/2021,09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSGS-E2S
Device Catalogue NumberH266
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/07/2021
Device Age1 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age15 YR
-
-