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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. NSK HANDPIECE, AIR-POWERED, DENTAL

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NAKANISHI INC. NSK HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Model Number TI-MAX X450YL
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Patient Problems Hemorrhage/Bleeding (1888); Injury (2348); Patient Problem/Medical Problem (2688)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative
Nakanishi did not receive any information about the patient, but is scheduled to visit the dentist to obtain the information. This event occurred in (b)(6), but similar products are marketed in the us under k112024.
 
Event Description
On january 20, 2020, nakanishi received a phone call from a dealer about an injury caused by an nsk handpiece. The information nakanishi obtained from the communication is as follows: the event occurred on (b)(6) 2020. A dentist was extracting the patient's #8 tooth using the ti-max x450yl handpiece (serial no. (b)(4)). During the procedure, the dentist found bleeding from an injury on the mucosa of the patient's cheek.
 
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Brand NameNSK
Type of DeviceHANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
NAKANISHI INC.
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
Manufacturer (Section G)
NAKANISHI INC.
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
Manufacturer Contact
kenneth block
800 e campbell rd.
suite 202
richardson, tx 
4809554
MDR Report Key9691406
MDR Text Key188811742
Report Number9611253-2020-00003
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTI-MAX X450YL
Device Catalogue NumberP1085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/11/2020 Patient Sequence Number: 1
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