MAUDE Adverse Event Report: NSK NAKANISHI INC FORZA M5 1:5 ATTACHMENT SHORTY FG HIGH SPEED OPTIC; HANDPIECE

Catalog Number	5027608U0
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer was using the handpiece during a cavity preparation.The handpiece was spinning and the doctor said it was louder than normal.The backcap of the handpiece got hot but the doctor didn't notice.He had it pressed up against the patient's lip.The patient was numb and by the time he was done the inside of the lip turned white with a slight burn.Lip burn cream was applied.

• Brand Name: FORZA M5 1:5 ATTACHMENT SHORTY FG HIGH SPEED OPTIC
• Common Device Name: HANDPIECE
• Manufacturer (Section D): NSK NAKANISHI INC; 700 shimohinata kanuma tochigi; 322-8 666; JA 322-8666
• MDR Report Key: 18469065
• Report Number: 1032227-2024-00001
• Device Sequence Number: 7285221
• Product Code: EGS
• UDI-Device Identifier: 00887919851400
• UDI-Public: 00887919851400
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/05/2024
• Report Date (Section F): 12/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5027608U0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2023
• Event Location: Other
• Date Report to Manufacturer: 12/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• 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: 25 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Date Report Sent to FDA: 12/05/2024