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

Model Number 420183

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/28/2017

Event Type  malfunction  

Event Description

During a robotic multiport cholecystectomy, the permanent cautery hook instrument got stuck in the robotic trocar inside the patient's abdomen.After approximately ten minutes, the trocar along with the instrument inside it was removed out of the patient's abdomen and released with force from the robotic arm.It was noted that there was a malfunction with the tip of the hook cautery at the joint.This was reported to the robotic representative.At this point, it was safe to proceed and continue in a robotic fashion.

• Brand Name: DAVINCI SI ENDOWRIST
• Type of Device: SYSTEM, SURGICAL, COMPUTER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd; sunnyvale CA 94086
• MDR Report Key: 6773232
• MDR Text Key: 82029168
• Report Number: 6773232
• 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: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 420183
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1