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

Device Problems Device Alarm System (1012); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

Event Description

While performing procedure (robotic assisted adrenalectomy) the unit froze with a fatal error code 40006 displayed on the monitor.Attempted to remove instruments.When unable to, called the intuit help line.Worked through to correct issue by turning off the system and restarting.Was able to continue procedure as planned.No patient harm.

• Brand Name: DAVINCI XI
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 9238701
• MDR Text Key: 163766139
• Report Number: 9238701
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11680 DA
• Patient Weight: 56