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

Model Number M0443802200202

Device Problems No Audible Prompt/Feedback (2282); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2021

Event Type  malfunction  

Event Description

Da vinci (si) robot continually states recoverable fault but will not clear fault when hitting "recover fault" button.Restart robot x2 and issue continues with error numbers 23017 and 23008.Have to bring another robot into room.Robot representative made aware of issue.

• Brand Name: DAVINCI SI ROBOT
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12165826
• MDR Text Key: 261471727
• Report Number: 12165826
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M0443802200202
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA