MAUDE Adverse Event Report: NAKANISHI INC. FORZA F5; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Model Number FORZA F5

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 12/28/2018

Event Type  Injury  

Manufacturer Narrative

Information about the ethnicity and race was not provided from the distributor.Due to the device not being returned from the distributor, nakanishi inc., (b)(4) (manufacturer) performed a dhr examination as an investigative approach.The dhr examination indicated that no problems occurred during manufacturing and testing of the subject device.

Event Description

On (b)(4) 2019, nakanishi received an email from a distributor ((b)(4)) about an nsk handpiece overheating.Details are as follows: the event occurred on (b)(6) 2018.A dentist was carrying out a pulpotomy on a patient using the forza f5 handpiece (serial no.(b)(4)).During the procedure, the dentist became aware of the handpiece overheating because the patient responded to the heat.The dentist found about a 3 cm x 3 cm burn injury on the inside of the patient's left cheek.No special medical treatment for the burn was provided to the patient.The patient is scheduled to return for a follow-up visit in a week.The dentist recommended over the counter pain medicine as needed.The dentist does not believe that there will be any scarring from the injury.

• Brand Name: FORZA F5
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: kenneth block ; 800 e campbell rd.; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 8339289
• MDR Text Key: 136144452
• Report Number: 9611253-2019-00006
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORZA F5
• Device Catalogue Number: 5021285U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR
• Patient Weight: 36