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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL ROBOT SYSTEM, SURGICAL COMPUTER CONTROLLED

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INTUITIVE SURGICAL ROBOT SYSTEM, SURGICAL COMPUTER CONTROLLED Back to Search Results
Model Number SHO672
Device Problems Poor Quality Image (1408); Calibration Problem (2890)
Patient Problem No Information (3190)
Event Date 09/20/2018
Event Type  malfunction  
Event Description
It was reported that the surgeon kept noticing blurred vision in the robotic console. We switched scopes and could not get the calibration issues resolved. Intuitive support was notified we used their advice to trouble shoot but were unable to fix the problem. Service rep will be here this afternoon to evaluate the system. Proceeded the case laparoscopically.
 
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Brand NameROBOT
Type of DeviceSYSTEM, SURGICAL COMPUTER CONTROLLED
Manufacturer (Section D)
INTUITIVE SURGICAL
MDR Report Key7901763
MDR Text Key121586500
Report NumberMW5080050
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSHO672
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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