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

Model Number 480422

Device Problems Retraction Problem (1536); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2021

Event Type  malfunction  

Event Description

Blade would not retract and instrument would not function properly, the device was taken out of the robotic arm and then reset, robot would not allow it to be used.

• 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: 12301159
• MDR Text Key: 265846590
• Report Number: 12301159
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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: L91201213
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1