MAUDE Adverse Event Report: NAKANISHI INC. S-MAX; DENTAL HANDPIECE

Model Number P1003001

Device Problems Unintended Ejection (1234); Loose or Intermittent Connection (1371)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  Injury  

Event Description

Nsk america received a report via email that a patient had swallowed a bur that came loose from the handpiece during operation.Nsk america has made multiple attempts to obtain further information about this event without success.The initial reporter has been contacted via email on the following dates with no response: (b)(6) 2020, (b)(6) 2021.A follow up report will be made as more information is received.

Event Description

During dental restoration procedure with patient under local anesthesia doctor noticed the bur was getting loose during cutting, the bur was changed immediately.After the bur change, the same device was used, and a polishing bur came loose from the device where it dropped into the patients throat and was ingested.The patient was sent to the emergency room for further evaluation.There were no adverse effects reported from ingestion of the bur and the patient has had a follow-up visit with the doctor and no further medical treatment was required for this adverse event.

• Brand Name: S-MAX
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 11135534
• MDR Text Key: 227088219
• Report Number: 1422375-2021-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P1003001
• Device Catalogue Number: M500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2021
• Distributor Facility Aware Date: 12/11/2020
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 68