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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 PHATELUS 45 TU
Device Problems Detachment Of Device Component (1104); Component Falling (1105); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Event Date 02/27/2017
Event Type  Injury  
Manufacturer Narrative
When nakanishi obtained the detailed information on the event from (b)(4) on (b)(6) 2017, the patient information was not included. According to the distributor, the dentist refused to provide the information. On (b)(6) 2017, nakanishi received a phone call from the distributor saying that the device involved in the event would not be returned. Due to the device not being returned from the distributor, nakanishi inc. , (b)(4)(manufacturer) made the dhr examination as the investigation approach. As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.
 
Event Description
On april 20, 2017, nakanishi received detailed information on the event. The event occurred on (b)(6) 2017. The procedure the dentist was performing at the time of the event was a molar extraction. The patient was under local anesthesia. After the patient swallowed the bur, the patient was x-rayed and the doctor determined that the bur had been naturally eliminated from the patient's body and no additional treatment was necessary.
 
Manufacturer Narrative
Nakanishi has not received any information about the patient from the distributor. Nakanishi will continue to obtain the information.
 
Event Description
On march 21, 2017, nakanishi received an e-mail from a distributor ((b)(4)) about a problem with an nsk handpiece. Details are as follows. - the date when the event occurred is unknown. - the bur was tested and there was no fault found. - a dentist was providing a dental treatment for a patient using phatelus 45 tu (serial no. (b)(4)). - during the procedure, the bur installed in the handpiece came off and the patient swallowed the bur. - the bur was not recovered.
 
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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
1201 richardson dr.
suite 160
richardson, TX 75080
9724809554
MDR Report Key6494003
MDR Text Key261587658
Report Number9611253-2017-00016
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K962543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Model NumberPHATELUS 45 TU
Device Catalogue NumberP639
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2008
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: 04/14/2017 Patient Sequence Number: 1
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