MAUDE Adverse Event Report: TTBIO CORP. SURGIPRO 45; HANDPIECE

Model Number 570-1732

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2021

Event Type  Injury  

Event Description

During a dental procedure, a straight fissure bur detached from the handpiece in the mouth.Patient was asked to not swallow anything, he immediately swallows before bur could be even suctioned.Patient was informed about the incident and asked to get a chest xray and kub done.

• Brand Name: SURGIPRO 45
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f, no.7, 6th road industry pa; taichung 40755 ; TW 40755
• MDR Report Key: 13510630
• MDR Text Key: 288211448
• Report Number: 3007007357-2022-00001
• 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: 02/11/2022,02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 570-1732
• Device Catalogue Number: 570-1732
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2022
• Distributor Facility Aware Date: 01/11/2022
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male