MAUDE Adverse Event Report: NAKANISHI INC. NL9000S; HANDPIECE, AIR-POWERED, DENTAL

Model Number NL9000S

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2015

Event Type  malfunction  

Event Description

Nakanishi received an email from (b)(6) 2016 that states a bur shot out of a handpiece while a dentist was working on a patient and the patient almost swallowed the bur.The dentist was sure that the bur was attached in the handpiece.According to the dentist, " nothing happened to the patient " and the dentist could not remember the exact patient involved in this event.

Manufacturer Narrative

Nakanishi sent two email messages to (b)(4) on february 4, 2016 and february 18, 2016 about requirements for additional patient information.Nakanishi received two email messages from (b)(4) on february 6, 2016 and february 23, 2016 that states (b)(4) was not able to obtain any patient information.

• Brand Name: NL9000S
• 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: ken block ; 1201 richardson dr.; suite 160; richardson, TX 75080 ; 9724809544
• MDR Report Key: 5436207
• MDR Text Key: 38793996
• Report Number: 9611253-2016-00004
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113655
• 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: 03/23/2016

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: Dentist
• Device Model Number: NL9000S
• Device Catalogue Number: 5012734U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2010
• 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