MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-40

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.System log review: a review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

Event Description

It was reported that during a da vinci-assisted hysterectomy procedure, the patient experienced a thermal burn.The patient burn occurred while the surgeon was placing the da vinci trocar ports, prior to the procedure.The surgeon was using an 11 blade, and cut the skin tissue when a superficial bleed occurred where the port site was going to be placed.The surgeon does not normally use a bovie pencil on the field, the green monopolar cord for the da vinci was used and placed on a laparoscopic spatula instrument to conduct monopolar energy.The surgeon then grabbed the bleeding vessel with a hemostat clamp and used the spatula instrument to activate the monopolar energy to the hemostat to burn the vessel to stop the bleeding.However, there was no reported "sizzle, burn or pop" on the vessel that would indicate the energy was activating the vessel.The bleeding did stop, and it was noticed that the patient experienced a thermal burn around the incision site where the trocar would be placed.No visible arcing occurred, the erbe settings was on 4 for all settings.The patient was in the lithotomy position, and the bovie pad was placed on the patients right posterior shoulder.There was no skin issues surrounding the bovie pad site.The surgeon placed the robotic trocar so the site, and proceeded with the hysterectomy robotically.The procedure was completed with no errors or complications, and specifically with the erbe.After the robot was undocked, a plastic surgeon was called and performed a wound excision to the patient's burn site, which was closed with suture.The estimated blood loss for the burn event due to the bleeding vessel was 5ml, and 50ml for the entire procedure.The patient remained hospitalized that night, which was reported to be the normal protocol and not related to the burn.The patient was discharged the following day with no complications and is reported to be recovering well.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 18434529
• MDR Text Key: 331801647
• Report Number: 2955842-2023-21334
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-40
• Device Catalogue Number: 381121
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White