MAUDE Adverse Event Report: TTBIO CORP. SURGIPRO 45 N/O FIXED END; HANDPIECE

Model Number SURGIPRO 45 FIXED END

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/05/2024

Event Type  malfunction  

Event Description

A 52 year old male patient swallowed a surgical bur fg 171, hs item code 100-7340 during a procedure.This handpiece was not holding the bur as expected.As a result of the patient swallowing the bur they had to undergo treatment at (b)(6) hospital to have it removed which it was.As the time this happened, the patient was relaxed, and did not notice swallowing the bur.

• Brand Name: SURGIPRO 45 N/O FIXED END
• Type of Device: 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: 19085813
• MDR Text Key: 339876996
• Report Number: 3010364969-2024-00006
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Model Number: SURGIPRO 45 FIXED END
• Device Catalogue Number: 570-1732
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male