MAUDE Adverse Event Report: INTUITIVE SURGICALDAVINCI S ROBOTSURGICAL ROBOT

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.

• Brand Name: DAVINCI S ROBOT
• Type of Device: SURGICAL 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 Key: 960945
• MDR Report Key: 991148
• Event Key: 950302
• Report Number: MW5005223
• Device Sequence Number: 1
• Product Code: NAY
• 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 Received: 01/30/2008
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device LOT Number: TKRID 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

#	Treatment	Treatment Date
NA