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

Model Number 381121-24

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 11/14/2023

Event Type  Injury  

Event Description

It was reported that after a da vinci-assisted hysterectomy with bilateral salpingo-oophorectomy surgical procedure, the energy setting that is normally set to 4, was actually set to 8 causing an electrical burn to the surgeon.An hour into the case, the surgeon decided to convert to open surgery due to the size of the mass.The surgeon explained that the mass would not have been able to be removed vaginally.The surgeon stated the decision to convert to open surgery was anticipated prior to starting the case.The patient was already grounded and the surgeon requested a 3rd party bovie pencil and generator with the setting of 50/50.Instead, the rn plugged the bovie pencil into the vio dv erbe generator and turned the setting up from 4 to 8 due to the surgeon requesting 50/50.According to the site's robotics coordinator, the rn was unaware of the difference in cautery settings between the different generators.With one hand, the surgeon had the bovie pencil and with the other hand, the surgeon had a finger under the patient's tissue.Upon energy activation, there was arcing and the bovie tip became embedded into the surgeon's finger.When this occurred, a shock was delivered, and the surgeon fell from the operating room table.The surgeon was able to proceed with the case and completed the surgical procedure abdominally.Afterwards, the surgeon went to the emergency room (er) where his finger was assessed; and bacitracin ointment was applied.

Manufacturer Narrative

There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Therefore, no product is expected to be returned.

• 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: 18352382
• MDR Text Key: 330812335
• Report Number: 2955842-2023-21117
• 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,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/20/2023

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: 381121-24
• Device Catalogue Number: 381121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/18/2023
• 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
• Patient Sex: Female