MAUDE Adverse Event Report: NAKANISHI INC. MASTER II HP PUSH BUTTON; HANDPIECE, AIR-POWERED, DENTAL

Model Number MASTER II HP PUSH BUTTON

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

When the distributor first communicated with the dental office for information about the event and the patient, the patient's weight, ethnicity and race were not provided.On january 26, 2018, the distributor made a second contact with the office for the missing information, however the dental office refused to provide the information.According to the distributor, the dental office has a repair center and sent the subject device to the center.Therefore, the device will not be returned to nakanishi inc., (b)(4) (manufacturer) for evaluation.Because the device was not returned, nakanishi conducted a 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 january 10, 2018, nakanishi received an email from a distributor (b)(4) about a headcap coming off from an nsk handpiece.The details are as follows.The event occurred on (b)(6) 2018.A dental hygienist was performing a dental procedure using a master ii hp push button (serial no.(b)(4)).During the procedure, the headcap suddenly came off and dropped in a patient's mouth.The headcap was retrieved and the patient was not injured.

• Brand Name: MASTER II HP PUSH BUTTON
• 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: 7230125
• MDR Text Key: 99000325
• Report Number: 9611253-2018-00003
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Hygienist
• Device Model Number: MASTER II HP PUSH BUTTON
• Device Catalogue Number: 9004609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2012
• 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: 50 YR