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 Burn(s) (1757)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

The reported event was addressed with phone support.The customer said the reported issue had not recurred in subsequent procedures and the erbe was working fine.The intuitive surgical, inc.(isi) field service engineer (fse) reviewed the system logs and found nothing related to the reported event.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.

Event Description

It was reported that after a urethral reimplantation da vinci-assisted general surgical procedure, a patient burn was noticed.The customer reported that the customer noticed a burn on patient and reported that it came from erbe.Upon additional follow-up with da vinci clinical territory associate (cta) it was stated that the surgeon was using a bovie monopolar cautery pen during port placement.Surgery was performed as expected and after the system was docked a small burn was noticed on the patient skin at the port site.The operating room staff confirmed that no errors or messages occurred during the surgery nor was there any issue with energy delivery.Additional information was obtained from the operating room manager who provided information stating that the surgeon was using the bovie under skin of the umbilical port site and he believes due to thermal spread made it up to skin on to the underside of port towards posterior direction.The size of the burn was small; further information on the burn such as severity is unknown.The burn was treated with burn ointment.Patient current status was stated to be fine.

• 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: 18077756
• MDR Text Key: 327473610
• Report Number: 2955842-2023-20026
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 381121-40
• Device Catalogue Number: 381121
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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: 64 YR
• Patient Sex: Female