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

Model Number SURGIPRO 45

Device Problems Unintended Ejection (1234); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2022

Event Type  Injury  

Event Description

While using this surgical handpiece as it was turned on, vibration dislodged a 557l surgical bur and the patient swallowed it.Medical treatment was not performed at the office.Abdominal radiographs initially and ct scan at a later date to make sure burr had passed in stool.The 64 year old male patient saw his primary doctor for follow up to make sure burr had passed.Patient was seen again for follow up and continuation of his treatment on (b)(6) 2022.The procedure is not known.

• 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: 14363782
• MDR Text Key: 294162073
• Report Number: 3007007357-2022-00007
• 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: 05/13/2022,05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SURGIPRO 45
• Device Catalogue Number: 570-1732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2022
• Distributor Facility Aware Date: 04/18/2022
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male