MAUDE Adverse Event Report: NAKANISHI INC. N-75S; HANDPIECE, AIR-POWERED, DETAL

Model Number N-75S

Device Problems Overheating of Device (1437); Physical Property Issue (3008); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 05/18/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016, nakanishi received an email from (b)(6) that states a handpiece had overheated and burned a patient.Details are as follows.The dentist was polishing a filling and a patient was burned with the head of handpiece.The injury occured at the end of procedure.The dentist wrote an rx for an analgesic to the patient.The dentist administered a special mouth wash to the patient.The dentist determined that there was no scarring to the patient.

Manufacturer Narrative

Nakanishi sent an email message to (b)(4) on july 1, 2016 to request patient's weight, which was missing in the initial report and repair history for handpiece serial number (b)(4).Nakanishi received an email message from (b)(4) on july 2, 2016 that states (b)(4) had no additional patient information and that there was no repair history found for this serial number.Due to the device not being returned from distributor, an examination of the dhr for device (n-75s, serial no.(b)(4)) is the only investigation approach nakanishi inc., (b)(4) (manufacturer) can make.As a result of the examination, the dhr indicated that no problems had occured during manufacturing and testing of the subject device.

• Brand Name: N-75S
• Type of Device: HANDPIECE, AIR-POWERED, DETAL
• 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 ; 1201 richardson dr.; richardson, TX 75080 ; 9724809554
• MDR Report Key: 5768741
• MDR Text Key: 49507960
• Report Number: 9611253-2016-00035
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: N-75S
• Device Catalogue Number: 5009801U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2014
• 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: 42 YR