MAUDE Adverse Event Report: NAKANISHI INC. OSSEOCISION 120V; CONTROLLER, FOOT, HANDPIECE AND CORD

Model Number OSSEOCISION 120V

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

Nakanishi did not receive information about the patient's age and weight.

Event Description

On march 22, 2017, nakanishi received an e-mail from a distributor ((b)(4)) about a problem with an nsk oral surgical unit.Details are as follows.- the event occurred on (b)(6) 2017.- a dentist was performing an oral surgery on a patient using osseocision ttf120.- suddenly, the error code 3 appeared on the monitor, and the drill unit did not work.- the dentist discontinued the procedure and sent the patient home.- the patient will be returned to the dental office when the unit is repaired.

Manufacturer Narrative

On august 8, 2017, nakanishi attempted to obtain information about the patient's age and weight from the distributor, however the information was not provided.Due to the device not being returned from the distributor, nakanishi inc., (b)(4) (manufacturer) made the dhr examination as the investigation approach.As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.

• Brand Name: OSSEOCISION 120V
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• 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 ; 1201 richardson dr.; suite 160; richardson, TX 75080 ; 9724809554
• MDR Report Key: 6493985
• MDR Text Key: 72839753
• Report Number: 9611253-2017-00018
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: OSSEOCISION 120V
• Device Catalogue Number: U371003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2006
• 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