MAUDE Adverse Event Report: TTBIO CORP HENRY SCHEIN; HANDPIECE

Model Number MAXIMA PRO 2L AR

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 02/15/2024

Event Type  Injury  

Event Description

Handpiece burst in patients mouth leading to minor injury.

Manufacturer Narrative

Handpieces were received on 03/21/2024 and evaluated on 03/22/2024.Initial report was amended to include evaluation results, see attached amended formal investigation report.

Event Description

Handpiece burst in patients mouth leading to minor injury.

• Brand Name: HENRY SCHEIN
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 18903740
• MDR Text Key: 337662285
• Report Number: 3007007357-2024-00006
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00304040133682
• UDI-Public: (01)00304040133682
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAXIMA PRO 2L AR
• Device Catalogue Number: 570-2094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2024
• Distributor Facility Aware Date: 02/15/2024
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male