MAUDE Adverse Event Report: NAKANISHI INC. SGM-E20RI; HANDPIECE, ROTARY BONE CUTTING

Model Number SGM-E20RI

Device Problem Mechanical Problem (1384)

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

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

Nakanishi did not receive any information about the patient and will try to obtain the information.

Event Description

On february 12, 2020, nakanishi received an e-mail from a distributor ((b)(4)) stating that a medwatch report (report no.#(b)(4)) had been submitted to fda about a problem with an nsk handpiece.The details of the event were as follows: the event occurred on (b)(6) 2020.A dentist was performing a dental procedure using the sgm-e20ri handpiece (serial no.(b)(4)).When the dentist activated the device in order to start cutting the patient's teeth during the procedure, the top of the handpiece would not allow the drills to engage and the handpiece would not spin.The dentist was unable to complete the procedure.The patient was under anesthesia.The patient was sent home and will return at a later date.

Manufacturer Narrative

Nakanishi sent emails to the distributor on (b)(6) 2020; (b)(6) 2021; and (b)(6) 2021, for further information about the event, including about the patient, plus whether or not the device involved in the event would be returned for investigation.No reply was received from the distributor.

• Brand Name: SGM-E20RI
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 9790358
• MDR Text Key: 196481021
• Report Number: 9611253-2020-00005
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• PMA/PMN Number: K970953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGM-E20RI
• Device Catalogue Number: Y110171
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other