MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-23

Device Problem Premature Activation (1484)

Patient Problem Burn(s) (1757)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.Site history complaint review was conducted and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.System error log review was conducted for a procedure on (b)(6) 2021 on system (b)(4).There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.The fenestrated bipolar forceps (fbf) instrument used in this procedure was pn: 471205-17 || ln: n13200831-0068 || sn: (b)(4) and it had 13 of 14 uses remaining and at the time of this review, has not been used in a subsequent procedure.While not all other reusable instruments used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against the instruments.The surgeon stated that there was no malfunction of a da vinci product and that the system and instruments worked as expected and as intended but the surgeon cited an audible tone hazard due to system sounds related to the foot activation pedals.Medical intervention was required due to an alleged audible tone deficiency leading to the surgeon¿s use-error of the pedals and inadvertent activation of instrument cautery function.At this time, the root cause of the customer reported failure mode cannot be determined or is unknown.

Event Description

It was initially reported that during a da vinci-assisted splenectomy surgical procedure, the surgeon was grasping the colon with a fenestrated bipolar forceps (fbf) instrument and when the surgeon went to activate a vessel sealer (vs) instrument for the spleen, the surgeon activated the incorrect foot pedal which activated the fbf instead which resulted in burning the colon.The surgeon ¿took¿ the burnt part of the colon which was described as, ¿not too big¿.The procedure completed robotically.The patient¿s status was unknown.On 17-feb-2021, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: during a da vinci-assisted splenectomy surgical procedure, the surgeon was grasping the colon with a fbf instrument approximately ¾ of the way through the procedure.When the surgeon went to activate a vessel sealer (vs) instrument, the surgeon activated the incorrect foot pedal which activated the energy for the fbf instrument instead; resulting in a burn to the colon.The issue occurred when the surgeon, ¿went to dissect fat off the kidney¿ but the surgeon was, ¿looking at the vs instrument, not the fbf instrument and accidentally pressed the wrong pedal¿.When the surgeon realized that the wrong instrument pedal was used, the surgeon, ¿zoomed out and saw burnt tissue¿.The only visible burnt tissue was colon tissue that was within the jaws of the fbf instrument which was described as less than the size of a quarter and black in color.The severity/degree of the burn was unknown.The surgeon, ¿marked the area with a circle of dots, using energy from a monopolar curved scissors (mcs) instrument to trace around and cut out¿ the burned tissue.The surgeon placed one suture thereafter to complete the repair intra-operatively.The surgeon used, ¿firefly icg to check colon perfusion¿ before and after the tissue removal.The procedure completed robotically without further incident and the patient was reported as doing well.

Manufacturer Narrative

Correction applied to the product being updated from patient side cart (psc) to surgeon side console (ssc).Psc pn: 380652-50 || sn: (b)(6) was updated to ssc system pn: 380677-23 || sn: (b)(6).

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 11468190
• MDR Text Key: 242467465
• Report Number: 2955842-2021-10238
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380677-23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES