MAUDE Adverse Event Report: TTBIO CORPORATION SURGIPRO45; HANDPIECE

Model Number SURGIPRO45

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/12/2021

Event Type  Injury  

Event Description

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.

Event Description

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: SURGIPRO45
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORPORATION; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer (Section G): TTBIO CORPORATION; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer Contact: kevin lin ; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• MDR Report Key: 13556947
• MDR Text Key: 285808675
• Report Number: 3010364969-2022-00004
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SURGIPRO45
• Device Catalogue Number: 570-1732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male