MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2019

Event Type  malfunction  

Event Description

After the robot was docked and the camera was being used to look laparoscopically into the patient's abdomen, the surgical technician noticed a white light shining through the camera light cord.After the surgical technician made the operating room staff aware, the charge nurse and sales rep were also notified.The rn in the room spoke on the phone with the rep who stated, the cord would need to be monitored for heat production if choosing to continue the case robotically, but would need to be removed and replaced immediately after the case.Charge rn made aware and then states that there is no current replacement light cord for this case.With this information, the surgeon decided to proceed with the robotic case with the pa and surgical technician monitoring the light cord throughout the entire case.The cord was immediately removed after the case was safely finished.No further incident occurred, and the patient was transferred to the pacu in stable condition.

• Brand Name: DA VINCI
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1090 kifer road; sunnyvale CA 94086
• MDR Report Key: 8539197
• MDR Text Key: 142752451
• Report Number: 8539197
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 04/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA