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

Model Number SURGIPRO 45

Device Problems Break (1069); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Product was used for the first time when the head part of the handpiece shattered while it was in the patient's mouth.

• Brand Name: SURGIPRO 45 N/O FIXED END
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 15433479
• MDR Text Key: 300027032
• Report Number: 3007007357-2022-00012
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2022
• Distributor Facility Aware Date: 08/18/2022
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Female