MAUDE Adverse Event Report: THINK SURGICAL INC. TSOLUTION ONE TOTAL KNEE APPLICATION; TCAT

Model Number 108400

Device Problem Off-Label Use (1494)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

There were no product malfunctions reported.The user did not retract the soft tissue while the robot was cutting as recommended in the ifu.The ifu provide the warning that failure to provide adequate soft tissue retraction or other methods of protection for critical soft tissue can cause soft tissue damage.The ifu also recommends that bone preparation, the surgeon should evaluate if additional soft-tissue retraction is needed.As well as a section dedicated to resetting soft-tissue retractors.The impact to the soft tissue was a nick along the incision line, and was compensated for upon suture.

Event Description

It was reported that during first femur cut, the tissue of the patient slipped out of surgeon's hands while he was retracting.The skin was nicked by cutter.The patient's bmi was 47.

• Brand Name: TSOLUTION ONE TOTAL KNEE APPLICATION
• Type of Device: TCAT
• Manufacturer (Section D): THINK SURGICAL INC.; 47201 lakeview blvd.; fremont CA 94538
• Manufacturer (Section G): THINK SURGICAL INC.; 47201 lakeview blvd; fremont; CA 94538
• Manufacturer Contact: meliha mulalic ; fremont, CA 94538 ; 5102492337
• MDR Report Key: 15899274
• MDR Text Key: 304682956
• Report Number: 3000719653-2022-00007
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2022

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 Model Number: 108400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female