MAUDE Adverse Event Report: NAKANISHI INC. N5000; HANDPIECE, AIR-POWERED, DENTAL

Model Number N5000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

As an investigational approach, nakanishi inc., (b)(4) (manufacturer) examined the dhr for the device (n5000, (b)(4)).Nakanishi concluded that no problems had occurred during manufacturing and testing of the subject device, as evidenced in the dhr.Nakanishi contacted the distributor ((b)(4)) to obtain the information about service history of the device, because nakanishi considered the possibility from many years of experience that the headcap had not been firmly fixed at the time of cartridge replacement, since the n5000 device has a replaceable cartridge in the head.According to (b)(4), the device was purchased (b)(6) 2014 and repaired twice (in (b)(6) 2014 and (b)(6) 2015).And the cartridge was replaced in the service.Serial no.Of original cartridge : (b)(4).Serial no.Of the cartridge at the time of event : (b)(4).Nakanishi will send an ai request letter to bsa and continue the investigation.

Event Description

On (b)(6) 2015, nakanishi was advised by (b)(4) of a device manufactured by nakanishi for (b)(4).(b)(4) received a handpiece returned for repair from a dentist.There was a note along with the handpiece indicating that a head cap had came off and had been swallowed by a patient during a dental procedure.The dentist was able to finish the procedure.The dentist determined that - no medical intervention is required - no permanent damage to patient is expected.There is no information on whether the head cap has passed through and out of the patient.There is also no detailed information about the patient because the dentist does not remember the staff member that was working with this patient.

Manufacturer Narrative

On october 14, 2016, nakanishi heard from the distributor that no additional information regarding the patient was available.

• Brand Name: N5000
• 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: kenneth block ; 800 e campbell rd.; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 5060048
• MDR Text Key: 25099500
• Report Number: 9611253-2015-00110
• 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: Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: N5000
• Device Catalogue Number: 5021274U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Supplement Dates Manufacturer Received: 10/14/2016
• Supplement Dates FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2014
• 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