MAUDE Adverse Event Report: TTBIO CORPORATION SURGIPRO 45; HANDPIECE

Model Number SURGIPRO 45

Device Problem Insufficient Information (3190)

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

Event Date 08/16/2022

Event Type  malfunction  

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.

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
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORPORATION; 2f., no. 7, 6th road; industry park; taichung, taiwan 40755 ; TW 40755
• Manufacturer (Section G): TTBIO CORPORATION; 2f., no.7, 6th road; industry park; taichung, taiwan 40755 ; TW 40755
• Manufacturer Contact: kevin lin ; 2f., no.7, 6th road; industry park; taichung, taiwan 40755 ; TW 40755
• MDR Report Key: 15517623
• MDR Text Key: 306413977
• Report Number: 3010364969-2022-00008
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SURGIPRO 45
• Device Catalogue Number: 570-1732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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 Age: 35 YR
• Patient Sex: Female