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

Catalog Number 5027608U0

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 12/20/2023

Event Type  Injury  

Event 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
• Type of Device: HANDPIECE
• Manufacturer (Section D): NSK NAKANISHI INC; 700 shimohinata kanuma tochigi; 322-8 666; JA 322-8666
• MDR Report Key: 18469065
• MDR Text Key: 332374007
• Report Number: 1032227-2024-00001
• Device Sequence Number: 1
• Product Code: EGS
• UDI-Device Identifier: 00887919851400
• UDI-Public: 00887919851400
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5027608U0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2023
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic