MAUDE Adverse Event Report: NAKANISHI INC. OSSEOCISION SURGICAL DRILL SYSTEM 120V

Catalog Number DS100US

Device Problem Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Date 02/23/2017

Event Type  Injury  

Event Description

It was reported that the drill unit gives the error code 3 and does not work.Patient was closed up and sent home.Patient will be returned to the office when the unit is repaired.

• Brand Name: OSSEOCISION SURGICAL DRILL SYSTEM 120V
• Type of Device: SURGICAL DRILL
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 6415383
• MDR Text Key: 70301938
• Report Number: 0001038806-2017-00097
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/23/2017,03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: DS100US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/23/2017
• Event Location: Other
• Date Report to Manufacturer: 02/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention