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

Model Number MLXT-SU

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Event Description

(b)(4).Event summary: according to (b)(4), a burr was detached from a handpiece during a treatment and the patient accidentally swallowed the burr.This event is under investigation.Nakanishi has requested additional information from the distributor and now is waiting for the information.However, nakanishi has started the evaluation process of the returned product.Nakanishi will submit additional information including results obtained through the investigation as a follow-up report.

• Brand Name: NSK MLXT-SU
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): NAKANISHI, INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken 322- 8666; JA 322-8666
• Manufacturer (Section G): NAKANISHI, INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken 322- 8666; JA 322-8666
• Manufacturer Contact: ken block ; 1201 richardson dr; suite 280; richardson, TX 75080 ; 9724809554
• MDR Report Key: 4746140
• MDR Text Key: 5769870
• Report Number: 9611253-2015-00067
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 04/30/2015

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?: Yes
• Device Operator: Other
• Device Model Number: MLXT-SU
• Device Catalogue Number: P620001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2005
• 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