MAUDE Adverse Event Report: NAKANISHI, INC. HENRY SCHEIN; MASTER II STANDARD

Catalog Number 900-4608

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 10/10/2022

Event Type  Injury  

Event Description

A 65 year old female patient was getting a crown removal on tooth#20.As the doctor started to remove the crown with the bur, the bur came out of the handpiece.The patient instructed not to swallow, but the patient swallowed anyway, a straight diamond bur.The patient did not cough or choke.The patient was advised to get a chest x-ray and decided not to get one.They had since been back to the office to continue planned treatment and has future treatment scheduled.

• Brand Name: HENRY SCHEIN
• Type of Device: MASTER II STANDARD
• Manufacturer (Section D): NAKANISHI, INC.; 700 shimohinata; kanuma; tochigi, tokyo 322-8 666; JA 322-8666
• MDR Report Key: 15763959
• MDR Text Key: 303394267
• Report Number: 2411236-2022-00006
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022,10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 900-4608
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2022
• Distributor Facility Aware Date: 10/24/2022
• Event Location: Other
• Date Report to Manufacturer: 11/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female