MAUDE Adverse Event Report: INTUITIVE SURGICALDAVINCI SURGICAL SYSTEMSURGICAL ROBOT

Model Number DA VINCI

Event Date 03/22/2007

Event Type  Injury   Patient Outcome  Required Intervention,Other

Event Description

During a cardiac robotic surgical procedure using a davinci surgical system, the robot's 3rd instrument arm (arm4) stopped functioning. The surgeon removed the instrument from the affected arm and placed it on arm1 after which the instrument tested okay. The surgeon then tried unsuccessfully to reattach the instrument to arm4 three different times, as instructed by the manufacturer's clinical representative, who was present during this surgical procedure. The surgeon had to make another incision in the patient to attach an atrium retraction instrument to complete the procedure. The manufacturer representative finally placed arm4 in the complete stow position and redeployed arm to a cold reboot status. After the reboot of arm4, the system was then able to detect the instrument and the surgeon completed the case without having to use the additional incision site, and without further robotic system failure.

• Brand Name: DAVINCI SURGICAL SYSTEM
• Type of Device: SURGICAL ROBOT
• Manufacturer (Section F): INTUITIVE SURGICAL; 950 kefer road; sunnyvale CA 94086
• Manufacturer (Section D): INTUITIVE SURGICAL; 950 kefer road; sunnyvale CA 94086
• Device Event Key: 824622
• MDR Report Key: 837314
• Event Key: 800210
• Report Number: 837314
• Device Sequence Number: 1
• Product Code: GCJ
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/26/2007

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/26/2007
• Is This An Adverse Event Report?: Yes
• Device Operator: Physician
• Device MODEL Number: DA VINCI
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No Answer Provided
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2007
• Device Age: 8 mo
• Event Location: Hospital
• Is the Device an Implant?: No
• Is this an Explanted Device?: No Answer Provided