MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST VESSEL SEALER EXTEND; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 480422

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2020

Event Type  malfunction  

Event Description

The device worked for the first part of the procedure.Then they opened the jaws and the blade in the jaw was exposed and the robot showed an error code saying the same.The instrument was taken out and put back in but then the robot gave the error code "unable to perform self test" so the device was taken out of use.

• Brand Name: ENDOWRIST VESSEL SEALER EXTEND
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 10792053
• MDR Text Key: 214801366
• Report Number: 10792053
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422
• Device Lot Number: M90200204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA