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

Model Number 5021285U0

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Pain (1994); Burn, Thermal (2530); Swelling/ Edema (4577)

Event Date 12/18/2020

Event Type  Injury  

Event Description

A dental handpiece (5021285uo forza f5 1:5 attachment optic) used for #19 crown prep got over-heated in the patient's mouth.The dentist did not know this was happening.It burned the inside of the patient's mouth.The dentist prescribed peridex to rinse her mouth.Later, the patient called the office to report the pain got worse with swelling.The dentist prescribed kenalog in orabase and a z-pack.The patient has not returned since the incident occurred.

Event Description

A dental handpiece (5021285uo forza f5 1:5 attachment optic) used for #19 crown prep got over-heated in the patient's mouth.The dentist did not know this was happening.It burned the inside of the patient's mouth.The dentist prescribed peridex to rinse her mouth.Later, the patient called the office to report the pain got worse with swelling.The dentist prescribed kenalog in orabase and a z-pack.The patient has not returned since the incident occurred.

• Brand Name: FORZA F5 1:5 ATTACHMENT OPTIC
• Type of Device: HANDPIECE
• Manufacturer (Section D): NSK NAKANISHI INC; 700 shimohinata kanuma tochigi; 322-8666; JA
• MDR Report Key: 11273772
• MDR Text Key: 230160334
• Report Number: 1032227-2021-00001
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): Y
• PMA/PMN Number: K182999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 01/25/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2021
• Distributor Facility Aware Date: 12/18/2020
• Event Location: Other
• Date Report to Manufacturer: 02/03/2021
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other