MAUDE Adverse Event Report: INTUITIVE SURGICAL INC DA VINCI ROBOT

Lot Number SH0404

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2017

Event Type  malfunction  

Event Description

During a partial nephrectomy, the 3rd arm of the robot stopped functioning.The light on the arm was blue indicating functioning, but physician could not take control of the arm.Patient was not harmed during procedure.

• Brand Name: DA VINCI ROBOT
• Type of Device: DA VINCI ROBOT
• Manufacturer (Section D): INTUITIVE SURGICAL INC; 1266 kifer dr ; sunnyvale CA 94086
• MDR Report Key: 6412623
• MDR Text Key: 70364226
• Report Number: MW5068508
• Device Sequence Number: 1
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: SH0404
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 114