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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL DA VINCI; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
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INTUITIVE SURGICAL DA VINCI; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2017
Event Type  malfunction  
Event Description
Davinci robot console right master malfunctioned after pt was intubated & prepped.Representative & davinci maintenance service was contacted & attempt was made to troubleshoot malfunction.The master arm was unable to be fixed & console was removed from the operating room (or); console from another or was taken after surgery was completed & set up in - representative was present after console transfer & the device was working properly.Manufacturer response for da vinci surgical robot, da vinci (per site reporter): representative came on site after console swap and issue has since been addressed.
 
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Brand Name
DA VINCI
Type of Device
SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL
1266 kifer road
sunnyvale CA 94086
MDR Report Key7057653
MDR Text Key92869332
Report Number7057653
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/20/2017,10/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/20/2017
Event Location Hospital
Date Report to Manufacturer09/20/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/24/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES; OTHER DEVICES IN USE: ALLEN STIRRUPS, GENERATOR GY
Patient Age44 YR
Patient Weight109
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