MAUDE Adverse Event Report: NAKANISHI INC. TI-MAX Z; DEANTAL HANDPIECE

Model Number Z800L

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Push button back cap came off in patients mouth during use.Patient was not affected.

• Brand Name: TI-MAX Z
• Type of Device: DEANTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 16000744
• MDR Text Key: 305680558
• Report Number: 1422375-2022-00052
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/01/2022,12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z800L
• Device Catalogue Number: P1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2022
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other