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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. DAVINCI ROBOT SYSTEM SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Lot Number M11171117
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2018
Event Type  malfunction  
Event Description
Davinci robot malfunction: while dissecting ovary "recovery fault error" appeared, blade exposed. Device replaced, no harm to patient.
 
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Brand NameDAVINCI ROBOT
Type of DeviceSYSTEM SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA 94086
MDR Report Key7406269
MDR Text Key104878128
Report NumberMW5076368
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberM11171117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2018
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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