MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, AIR-POWERED, DENTAL

Model Number PAE-T M4

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, nakanishi received an e-mail from a distributor (nsk (b)(6)) about a problem with an nsk dental product.Details are as follows.The event occurred on (b)(6) 2022.The dentist was removing caries from teeth of the patient's lower left jaw using the pae-t m4 handpiece (serial no.(b)(4)).During the procedure, the headcap dropped in the patient's mouth and the patient spat out the headcap.The patient was not injured in the event.

Manufacturer Narrative

Nakanishi is still trying to obtain information about the patient weight.

Manufacturer Narrative

On january 13, 2023, nakanishi received an email from the distributor (nsk shanghai) stating that since the device involved in the event had been returned to the dentist, the device was not available for investigation.Due to the device not being returned from the distributor, nakanishi examined the device history record (dhr) for the subject pae-t m4 device [serial no.(b)(6)].As a result of the examination, nakanishi found that the dhr indicated than no problems occurred during manufacturing and testing of the subject device.According to the distributor, the dentist did not provide the patient's weight.

• Brand Name: NSK
• Type of Device: HANDPIECE, AIR-POWERED, 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: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; 2245128921
• MDR Report Key: 16010964
• MDR Text Key: 306181422
• Report Number: 9611253-2022-00087
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PAE-T M4
• Device Catalogue Number: T134
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2012
• 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: 32 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian