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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. DAVINCI SI ROBOT SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number M0443802200202
Device Problems No Audible Prompt/Feedback (2282); Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 07/15/2021
Event Type  malfunction  
Event Description
Da vinci (si) robot continually states recoverable fault but will not clear fault when hitting "recover fault" button. Restart robot x2 and issue continues with error numbers 23017 and 23008. Have to bring another robot into room. Robot representative made aware of issue.
 
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Brand NameDAVINCI SI ROBOT
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12165826
MDR Text Key261471727
Report Number12165826
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 Other Health Care Professional
Type of Report Initial
Report Date 07/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0443802200202
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/02/2021
Event Location Hospital
Date Report to Manufacturer07/14/2021
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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