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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. NSK DENTAL HANDPIECE

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NAKANISHI INC. NSK DENTAL HANDPIECE Back to Search Results
Model Number Z800L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2020
Event Type  Injury  
Event Description
Patient swallowed bur when it came loose from the chuck during crown removal procedure on #15 tooth. Routine x-rays have been taken to monitor progress through the gastro-intestinal tract and ensure excretion. No further medical treatment required at this time.
 
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Brand NameNSK
Type of DeviceDENTAL HANDPIECE
Manufacturer (Section D)
NAKANISHI INC.
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
MDR Report Key10003592
MDR Text Key191246864
Report Number1422375-2020-00011
Device Sequence Number1
Product Code EFB
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 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberZ800L
Device Catalogue NumberP1110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/2020
Distributor Facility Aware Date03/12/2020
Device Age5 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer04/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/27/2020 Patient Sequence Number: 1
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