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

Catalog Number 5021262U0

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 03/12/2018

Event Type  Injury  

Event Description

A bur slipped out of the handpiece.The patient swallowed.Medical intervention / hospitalization noted on complaint form.Not able to obtain any patient identification or details after repeated attempts to contact.

• Brand Name: NL9000S
• Type of Device: DENTAL HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): NAKANISHI INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken, 322-8 6666; JA 322-86666
• MDR Report Key: 7441515
• MDR Text Key: 105874281
• Report Number: 1032227-2018-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/18/2018

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 Catalogue Number: 5021262U0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2018
• Distributor Facility Aware Date: 03/22/2018
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 04/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other