MAUDE Adverse Event Report: NSK NAKANISHI INC FORZA F5 1:5 ATTACHMENT OPTIC; HANDPIECE

Model Number 5021285U0

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 03/01/2023

Event Type  Injury  

Event Description

During a root canal on tooth #12, the patient suffered a 3mm burn to upper lip.The patient was given vitamin e ointment and will follow-up in 2 weeks.

• Brand Name: FORZA F5 1:5 ATTACHMENT OPTIC
• Type of Device: HANDPIECE
• Manufacturer (Section D): NSK NAKANISHI INC; 700 shimohinata kanuma tochigi; 322-8 666; JA 322-8666
• MDR Report Key: 16520582
• MDR Text Key: 311041636
• Report Number: 1032227-2023-00003
• Device Sequence Number: 1
• Product Code: EGS
• UDI-Device Identifier: 00887919660040
• UDI-Public: (01)00887919660040
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5021285U0
• Device Catalogue Number: 5021285U0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2023
• Distributor Facility Aware Date: 03/02/2023
• Event Location: Other
• Date Report to Manufacturer: 03/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 61 KG