MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST; DAVINCI SI; SYSTEM, SURGICAL, COMPUTER

Model Number 420179

Device Problems Loss of Power (1475); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 01/27/2017

Event Type  malfunction  

Event Description

The robotic scissor stopped working inside of patient.

• Brand Name: ENDOWRIST; DAVINCI SI
• Type of Device: SYSTEM, SURGICAL, COMPUTER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6683893
• MDR Text Key: 78957284
• Report Number: 6683893
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2017

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: Physician
• Device Model Number: 420179
• Device Lot Number: 10161014056
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR