MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC.; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Device Problems Device Displays Incorrect Message (2591); Computer Operating System Problem (2898); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2020

Event Type  malfunction  

Event Description

The surgeon was attempting to manipulate robot arm #3 at the end of the procedure and a recoverable fault error occurred.Robot arm #3 became frozen.

• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 10733192
• MDR Text Key: 212997928
• Report Number: 10733192
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1