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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. NSK; MICRO SURGERY HANDPIECE
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NAKANISHI INC. NSK; MICRO SURGERY HANDPIECE Back to Search Results
Model Number SGS-E2S
Device Problem Overheating of Device (1437)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 06/03/2021
Event Type  Injury  
Event Description
During a tooth extraction procedure patient complained that she felt heat on her lower lip.Doctor stopped the procedure and felt the handpiece was very hot to the touch.Doctor noted some redness on the patients lip with no blistering.No medical treatment was required at the time of the event and the patient has reported no complications.Office was unable to determine through their records which of two possible devices caused the injury so a report will be made for both device serial numbers.This report is the second of two.
 
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Brand Name
NSK
Type of Device
MICRO SURGERY HANDPIECE
Manufacturer (Section D)
NAKANISHI INC.
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA  322-8666
MDR Report Key12162203
MDR Text Key262178784
Report Number1422375-2021-00016
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 Physician Assistant
Type of Report Initial
Report Date 07/13/2021,06/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSGS-E2S
Device Catalogue NumberH266001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2021
Distributor Facility Aware Date06/14/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
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