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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. NSK; SURGICAL HANDPIECE
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NAKANISHI INC. NSK; SURGICAL HANDPIECE Back to Search Results
Model Number SGA-E2S
Device Problem Overheating of Device (1437)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 11/09/2019
Event Type  Injury  
Event Description
On (b)(6) 2019 doctor (b)(6) was performing a removal of horizontal impacted tooth #17 on the patient under local anesthesia when the tip of the handpiece overheated and caused a thermal burn to the patients lower left lip.The patient was instructed by the doctor to apply ointment to treat the injury site.The burn is reported to be healing normally but may leave a permanent scar which may require referral to a specialist for treatment.
 
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Brand Name
NSK
Type of Device
SURGICAL HANDPIECE
Manufacturer (Section D)
NAKANISHI INC.
700 shimohinata
kanuma-shi, 322-8 666
JA  322-8666
MDR Report Key9369862
MDR Text Key168054801
Report Number1422375-2019-00021
Device Sequence Number1
Product Code KMW
UDI-Device Identifier04560264556287
UDI-Public04560264556287
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 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSGA-E2S
Device Catalogue NumberH265001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/25/2019
Distributor Facility Aware Date11/13/2019
Device Age2 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age23 YR
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