MAUDE Adverse Event Report: NAKANISHI, INC. HENRY SCHEIN; MASTER II HP PUSH BUTTON

Catalog Number 900-4609

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2018

Event Type  Injury  

Event Description

A dental hygienist was using the handpiece when the back end of the handpiece where the button releases, the button popped off the handpiece and landed into the patient' s mouth.The piece was able to be retrieved.The patient was not harmed.

• Brand Name: HENRY SCHEIN
• Type of Device: MASTER II HP PUSH BUTTON
• Manufacturer (Section D): NAKANISHI, INC.; 700 shimohinata; kanuma-shi; tochigi-ken tokyo, 322-8 666; JA 322-8666
• MDR Report Key: 7222481
• MDR Text Key: 98413086
• Report Number: 2411236-2018-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial
• Report Date: 01/26/2018,01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Catalogue Number: 900-4609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2018
• Distributor Facility Aware Date: 01/04/2018
• Event Location: Other
• Date Report to Manufacturer: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR