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

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.

• Brand Name: NSK
• Type of Device: HANDPIECE, 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 75081 ; 9724809554
• MDR Report Key: 8751795
• MDR Text Key: 149768499
• Report Number: 9611253-2019-00034
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112673
• Number of Events Reported: 1
• 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 Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PMN-HP
• Device Catalogue Number: T797010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR