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Model Number PMN-HP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling (2091); Patient Problem/Medical Problem (2688)
Event Date 06/08/2019
Event Type  Injury  
Manufacturer Narrative
Upon receiving the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device. These activities are described in more detail below. Methodology used: nakanishi examined the device history record and the repair history for the subject pmn-hp device [serial number (b)(4)]. There were no problems observed during manufacturing or testing noted in the dhr. There were also no repair history records since the device was shipped. Nakanishi performed an operation check in accordance with inspection standard for repair ((b)(4)). Nakanishi confirmed that all specifications in the standard were satisfied in the evaluation. Air consumption: 12. 1 nl/min (acceptance criteria: 7 -15 nl/min). Pressure at the hp house connection point. Air pressure: 0. 35 mpa (acceptance criteria: 0. 35 mpa). Water pressure: 0. 06 mpa (acceptance criteria: 0. 06 mpa). Water flow rate: 40. 5 ml/min (acceptance criteria: 30 ml/min or greater). Water spray: no abnormalities observed. Connection: no abnormalities observed. Conclusions reached based on the investigation and analysis results: nakanishi could not identify the exact cause of the patient's emphysema because nakanishi did not observe any abnormalities in the operation check. In spite of the fact that nakanishi did not identify the cause, nakanishi took the following actions to be safe. Nakanishi reviewed the operation manual and reconfirmed that there was a warning for emphysema in the manual. Nakanishi reported the above evaluation results to the dentist and reminded the dentist of the importance of using the device as instructed in the operation manual.
Event Description
On june 12, 2019, nakanishi received a phone call from a dealer about the nsk handpiece problem. Upon receipt of the information, nakanishi visited the dental office to hear details. The details nakanishi obtained from the dentist are as follows. The event occurred on (b)(6) 2019. The dentist was removing stains/plaque from the surfaces of the patient's teeth using the pmn-hp handpiece (serial no. (b)(4)). The patient was not under anesthesia. During the procedure, the patient complained about discomfort in the face. The dentist noticed that a subcutaneous emphysema had developed from the patient's orbital floor to the lateral surface of the lower right jaw. The patient went to see an otolaryngologist and received treatment. On (b)(6) 2019, the patient returned to the dental office for a follow-up visit and the dentist observed that the injury was healing normally.
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Brand NameNSK
Manufacturer (Section D)
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
Manufacturer (Section G)
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
Manufacturer Contact
kenneth block
800 e campbell rd.
suite 202
richardson, TX 75081
MDR Report Key8751795
MDR Text Key149768499
Report Number9611253-2019-00034
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
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
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPMN-HP
Device Catalogue NumberT797010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2012
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: 07/02/2019 Patient Sequence Number: 1