MAUDE Adverse Event Report: INTUITIVE SURGICAL ROBOT; SYSTEM, SURGICAL COMPUTER CONTROLLED

Model Number SHO672

Device Problems Poor Quality Image (1408); Calibration Problem (2890)

Patient Problem No Information (3190)

Event Date 09/20/2018

Event Type  malfunction  

Event Description

It was reported that the surgeon kept noticing blurred vision in the robotic console.We switched scopes and could not get the calibration issues resolved.Intuitive support was notified we used their advice to trouble shoot but were unable to fix the problem.Service rep will be here this afternoon to evaluate the system.Proceeded the case laparoscopically.

• Brand Name: ROBOT
• Type of Device: SYSTEM, SURGICAL COMPUTER CONTROLLED
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 7901763
• MDR Text Key: 121586500
• Report Number: MW5080050
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SHO672
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1