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 Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A tooth 12,13 and 14 interproximal procedure was being performed.The handpiece was used at the normal speed while using water and no unusual noises were noticed.The doctor paused to change the bur and noticed a 10mm long burn on the lower left lip matching the handpiece.It was a second degree burn.Water was run over the lip for 10 minutes then the patient was sent to a plastic surgeon.The plastic surgeon had to unroof the wound.The patient will have to return to the plastic surgeon for other visits.Currently, the patient has no sensation.

• Brand Name: FORZA F5 1:5 ATTACHMENT OPTIC
• Common Device Name: HANDPIECE
• Manufacturer (Section D): NSK NAKANISHI INC; 700 shimohinata kanuma tochigi; 322-8666, jpn, ; JA
• MDR Report Key: 16432729
• Report Number: 1032227-2023-00001
• Device Sequence Number: 14179382
• Product Code: EGS
• UDI-Device Identifier: 00887919660040
• UDI-Public: (01)00887919660040
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2023
• Report Date (Section F): 02/23/2023

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: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/06/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/23/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2023
• 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: Required Intervention; Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 02/23/2023