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

Model Number SURGIPRO 45 N/O 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  Injury  

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.At the time this happened, the patient was relaxed, and did not notice swallowing the bu.

• Brand Name: SURGIPRO 45 N/O FIXED END
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO; 2f, 7 6th road; industry pa, taichung 40755 ; TW 40755
• MDR Report Key: 18886712
• MDR Text Key: 337450976
• Report Number: 3007007357-2024-00004
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2024,03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SURGIPRO 45 N/O FIXED END
• Device Catalogue Number: 570-1732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Distributor Facility Aware Date: 02/15/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/15/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male