MAUDE Adverse Event Report: TTBIO CORP. MAXIMA ELITE ML MINI HEAD; HANDPIECE

Model Number	MAXIMA ELITE ML MINI HEAD
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
At first, the doctor was having "pressure and not cutting issues" with the product.The doctor sent the product over to pro repair.Then, after receiving the product, the doctor used the handpiece on a 6 year old male patient and it exploded in the patients mouth.The patient was sedated and they were able to retrieve all the parts.The patient is in good condition.
Event or Problem Description
At first, the doctor was having "pressure and not cutting issues" with the product.The doctor sent the product over to pro repair.Then, after receiving the product, the doctor used the handpiece on a 6 year old male patient and it exploded in the patients mouth.The patient was sedated and they were able to retrieve all the parts.The patient is in good condition.

• Brand Name: MAXIMA ELITE ML MINI HEAD
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer (Section G): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer Contact: jun li ; 2f., no.7, 6th road; industry park; taichung, 40755
• MDR Report Key: 19391236
• Report Number: 3010364969-2024-00010
• Device Sequence Number: 12499220
• Product Code: EFB
• UDI-Device Identifier: 00304040058336
• UDI-Public: (01)00304040058336
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: MAXIMA ELITE ML MINI HEAD
• Device Catalogue Number: 570-0108
• Device Lot Number: 74017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR
• Patient Sex: Male