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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. DA VINCI ROBOT XI SURGICAL SYSTEM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number XI-SS4000
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 12/13/2017
Event Type  Injury  
Event Description
Patient was admitted for a robot assisted laparoscopic transabdominal retroperitoneal lymph node dissection and left spermatic cord resection. A blunt trochar was placed, and 6 ports were placed under direct vision. The robot arms were placed in standard fashion to triangulate the retroperitoneum. The da vinci xi robotic system was then docked over the patient's flank. Initial inspection of the bowel and abdominal contents were uncomplicated, with no evidence of injury. The procedure was initiated with mobilization of the colon to reveal the retroperitoneum. The spermatic cord was then identified at its origin on the left renal vein. At this point the robotic system alerted and an unrecoverable fault in the 3rd robotic arm was discovered. The arm was locked in place and the procedure could not continue. The error code 319 was noted and the arm could not be moved. The surgeon and team followed the instructions on the screen and rebooted the system three times without resolution. They called the intuitive inc. Support and the da vinci rep tried to trouble shoot the problem without success. The final advice was a robotic arm replacement the following day. The surgeon was told that it was a complete failure of the robot. The case was aborted after the gonadal veins were ligated and the remaining distal portion of the spermatic cord was dissected free. The patient returned for additional surgery a few days later. Manufacturer response for da vinci robot xi surgical system, da vinci robot xi (per site reporter): the manufacturer repaired the device the following day and has the broken parts.
 
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Brand NameDA VINCI ROBOT XI SURGICAL SYSTEM
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd
sunnyvale CA 94086
MDR Report Key7137532
MDR Text Key95480186
Report Number7137532
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/19/2017,12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberXI-SS4000
Other Device ID NumberSURGEON CONSOLE 396891, PT. S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/19/2017
Event Location Hospital
Date Report to Manufacturer12/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/21/2017 Patient Sequence Number: 1
Treatment
ATTACHMENTS TO THE ROBOT
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