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

Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Event Description

Per report: during partial nephrectomy robot alarmed unrecoverable fault, robot system shut itself down during critical portion of procedure while patient was bleeding.Robot rebooted itself without any manual adjustments from staff, loss of hand controls was lost briefly while robot was powering itself up.Da vinci tech support was called to remotely check the system.No patient harm.

• Brand Name: DA VINCI SI SURGICAL SYSTEM
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7780266
• MDR Text Key: 117013289
• Report Number: 7780266
• 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: 07/31/2018,06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 07/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Weight: 143