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

Model Number Z95L

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 06/29/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, nakanishi became aware of a handpiece overheating through a complaint input into the complaint database by a distributor ((b)(6)).Details are as follows: the event occurred on (b)(6) 2020.The dentist was performing a crown preparation for the patient's tooth #31 using the z95l handpiece (serial no.(b)(4)).The patient was under local anesthesia.During the procedure, the patient received a burn to the top right side of his tongue approximately 24mm in size.The patient was referred to an ent specialist for further treatment of the burn and the injury is reported to be healing normally.It was determined that no further medical treatment was required.

• Brand Name: NSK
• 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 ; 4809554
• MDR Report Key: 10360312
• MDR Text Key: 207522048
• Report Number: 9611253-2020-00033
• 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: company representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z95L
• Device Catalogue Number: C1034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2016
• 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: 48 YR
• Patient Weight: 79