MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, ROTARY BONE CUTTING

Model Number X-SG20L

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

Nakanishi is now trying to obtain further information about the event including the patient information.

Event Description

On (b)(6) 2018, nakanishi received an e-mail from a distributor ((b)(4)) about a patient's accidental ingestion of a spray pipe.Details are as follows: the event occurred on (b)(6) 2018.A dentist was performing a dental procedure using an x-sg20l handpiece (serial no.(b)(4)), which has an external water spray.During the procedure, the external spray pipe suddenly broke off and fell in the patient's mouth, and the patient swallowed the spray pipe.

Manufacturer Narrative

Nakanishi took the following actions to obtain further information about the event including information about the patient, however no additional information was provided.In august, 2018 (the exact date unknown), nakanishi made a phone call to the distributor.In september, 2018 (the exact date unknown), nakanishi made a phone call to the distributor again.On january 31, 2019, an e-mail arrived from the distributor, but no additional information was included.

• Brand Name: NSK
• 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: 7980243
• MDR Text Key: 124307104
• Report Number: 9611253-2018-00047
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• PMA/PMN Number: K173905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SG20L
• Device Catalogue Number: C1003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other