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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ROBOTIC LENS 30 DEGREE SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ROBOTIC LENS 30 DEGREE SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Failure to Calibrate (2440)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2020
Event Type  No Answer Provided  
Event Description
We had a 30-degree robotic lens that would not calibrate. The lens was taken off the field and we used another lens for the case. We put it on the side and the robotic coordinator hooked the lens up to the robot and it worked fine. They could not duplicate the issue. We have called intuitive rep. To look at the lens and see if he can duplicate the problem. He says that sometimes there is a buildup on the connection and that can cause the issue. No patient harm.
 
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Brand NameROBOTIC LENS 30 DEGREE
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key10319483
MDR Text Key200214630
Report Number10319483
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 07/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/21/2020
Event Location Hospital
Date Report to Manufacturer07/24/2020
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

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