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

Model Number 381121

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/16/2023

Event Type  Injury  

Event Description

On 12/11/2023, intuitive surgical, inc.(isi) received mw5147810 stating: the reported event was that a patient was burned when a bovie monopolar cautery pen was connected to the erbe electrical surgical unit (esu) generator.The customer indicated that they used the bovie cautery too close to a metal clamp which caused the energy to arc and burn the patient.The burns were found around and under the metal clamp.This report reflects information received by fda in the form of a notification per 803.22(b)(2).

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined since the bovie pen is not manufactured by intuitive.

• 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: 18489867
• MDR Text Key: 332602323
• Report Number: 2955842-2023-21631
• Device Sequence Number: 1
• Product Code: NAY
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 381121
• Device Catalogue Number: 381121
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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