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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. DAVINCI XI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 380677
Device Problem Poor Quality Image (1408)
Patient Problem Insufficient Information (4580)
Event Date 02/23/2021
Event Type  malfunction  
Event Description
Patient was here for robotic prostatectomy procedure. After the robot was docked, the surgeon broke scrub to sit down at console to begin robotic portion of procedure. Surgeon stated that the vision from right eye of scope was dark. That scope was replaced with new scope but same thing happened, but this time left eye of scope was dark. Robot was undocked and rebooted. Staff was unable to correct the problem. A call was placed to davinci support and troubleshooting recommendations were not able to correct the problem. Surgeon aborted procedure and patient was woken up.
 
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Brand NameDAVINCI XI
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key11412278
MDR Text Key234689083
Report Number11412278
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/25/2021
Event Location Hospital
Date Report to Manufacturer03/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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