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 SGS-E2S; 1:2 STRAIGHT SURGICAL
  • 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 SGS-E2S; 1:2 STRAIGHT SURGICAL Back to Search Results
Model Number SGS-E2S
Device Problem Insufficient Information (3190)
Patient Problem Burn, Thermal (2530)
Event Date 03/05/2015
Event Type  Injury  
Event Description
On (b)(6) 2015 nsk america corp was made aware that a pt may have been burned by a nsk handpiece.Two handpieces were sent by doctor.Doctor not sure which hand piece was used.The handpieces (sgs-e2s) serial number (b)(4) were rec'd on march 25, 2015.We learned that the pt had burned lips.Doctor stated 2nd degree burn- l commissure lower lib during extraction of wisdom teeth.Pt had no permanent damage and treated with antibacterial ointment applied.Reported injury healing normally.This report is for serial number (b)(4) on report #1422375-2015-00006.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NSK SGS-E2S
Type of Device
1:2 STRAIGHT SURGICAL
Manufacturer (Section D)
NAKANISHI INC
700 shimohinata
kanuma-shi, tochigi-ken 322- 8666
JA  322-8666
MDR Report Key4742939
MDR Text Key5703717
Report Number1422375-2015-00007
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
Source Type Unknown
Reporter Occupation Dentist
Type of Report Initial
Report Date 04/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberSGS-E2S
Device Catalogue NumberH265
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/16/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2015
Event Location Other
Date Report to Manufacturer04/16/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age16 YR
Patient Weight54
-
-