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

Model Number	5021285U0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The dentist was performing a composite filling on teeth #4 and #31.The patient was burned on the inside right cheek.The burn was the size of a quarter.There was no follow-up treatment.
Event or Problem Description
The dentist was performing a composite filling on teeth #4 and #31.The patient was burned on the inside right cheek.The burn was the size of a quarter.There was no follow-up treatment.

• Brand Name: FORZA F5 1:5 ATTACHMENT OPTIC
• Common Device Name: HANDPIECE
• Manufacturer (Section D): NSK NAKANISHI INC; 700 shimohinata kanuma tochigi; 322-8 666; JA 322-8666
• MDR Report Key: 16520439
• Report Number: 1032227-2023-00002
• Device Sequence Number: 19456154
• Product Code: EGS
• UDI-Device Identifier: 00887919660040
• UDI-Public: (01)00887919660040
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023
• Report Date (Section F): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5021285U0
• Device Catalogue Number: 5021285U0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/01/2023
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 03/13/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Date Report Sent to FDA: 03/13/2023