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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICALDAVINCI S ROBOTSURGICAL ROBOT

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INTUITIVE SURGICAL DAVINCI S ROBOT SURGICAL ROBOT   Back to Search Results
Lot Number TKRID 46641
Event Date 12/21/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Robot assisted prostatectomy had frequent error messages from robot. Davinci rep called but unable to fix problem; error codes began more frequently and resulted in inability to override. Robotic assist procedure aborted and surgeon proceeded with an open prostatectomy instead. Follow-up: manufacturer repaired robot in 2007.

 
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Brand NameDAVINCI S ROBOT
Type of DeviceSURGICAL ROBOT
Manufacturer (Section F)
INTUITIVE SURGICAL
1266 kifer rd
building 101
sunnyvale CA 94086 5304
Manufacturer (Section D)
INTUITIVE SURGICAL
1266 kifer rd
building 101
sunnyvale CA 94086 5304
Device Event Key960945
MDR Report Key991148
Event Key950302
Report NumberMW5005223
Device Sequence Number1
Product CodeNAY
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/14/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device LOT NumberTKRID 46641
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 01/30/2008 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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