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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICALDAVINCI SURGICAL SYSTEMSURGICAL ROBOT

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INTUITIVE SURGICAL DAVINCI SURGICAL SYSTEM SURGICAL ROBOT   Back to Search Results
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.

 
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Brand NameDAVINCI SURGICAL SYSTEM
Type of DeviceSURGICAL 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 Key824622
MDR Report Key837314
Event Key800210
Report Number837314
Device Sequence Number1
Product CodeGCJ
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 Received03/26/2007
Is This An Adverse Event Report? Yes
Device Operator Physician
Device MODEL NumberDA 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 FDA03/26/2007
Device Age8 mo
Event Location Hospital
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

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