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

Model Number 5021285U0

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 01/31/2023

Event Type  Injury  

Event 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
• Type of Device: HANDPIECE
• Manufacturer (Section D): NSK NAKANISHI INC; 700 shimohinata kanuma tochigi; 322-8666, jpn, ; JA
• MDR Report Key: 16432729
• MDR Text Key: 310128758
• Report Number: 1032227-2023-00001
• 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: Physician
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2023
• Distributor Facility Aware Date: 02/06/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White