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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC NSK SGS-E2S; 1:2 STRAIGHT SURGICAL
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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 03/06/2015
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) and serial number (b)(4) were rec'd on (b)(6) 2015.We learned that the pt had burned lips.Doctor stated 2nd degree burn r commissure lower lip during extraction of wisdom teeth.Pt had no permanent damage and treated with antibacterial ointment applied.Report injury healing normally.This report is for serial number (b)(4) and reported serial number (b)(4) on report #1422378-2015-00010.
 
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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 Key4742940
MDR Text Key5884150
Report Number1422375-2015-00009
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 Dental Hygienist
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
Distributor Facility Aware Date03/25/2015
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 Age31 YR
Patient Weight104
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