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

Model Number 380677-03

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the intra-operative complication can be attributed to the surgeon inadvertently pressing the wrong pedal while intending to activate the foot pedal for the stapler instrument.No products are expected for return to isi for evaluation as there was no product issue as per the surgeon.If additional information is received, a follow-up mdr will be submitted.An isi clinical development engineer (cde) who was present during the procedure stated the surgeon was trying to clamp the stapler down when he inadvertently put his foot on the right blue pedal (for the cbd instrument) instead of the left blue pedal (for the stapler instrument), and activated the pedal for a short time.Per the cde, the image of the screen showed that his foot was hovering over right blue pedal, followed by an image of the short activation.According to the cde, the surgeon immediately then moved his foot to the left blue pedal and clamped and fired the stapler instrument.A video of the reported event was reviewed by an isi sp advanced instruments product manager and the following was noted: at the beginning of this clip, the surgeon¿s right hand (curved bipolar dissector) is holding vessel loop under a pulmonary vessel, and the sureform 45 curved tip stapler with a white reload (left hand) is in view.The surgeon then proceeds to place the anvil tip of the stapler underneath the pulmonary vessel.When the stapler jaws were fully around the vessel, the vessel loop is pulled out from underneath the vessel and is positioned at the bottom right corner of the view by the curved bipolar dissector.The curved bipolar dissector itself is positioned out of view.The surgeon closedthe stapler jaws, and prepares to clamp the stapler.While the curved bipolar dissector is out of view, the surgeon put his foot over the associated blue pedal, as seen by the green outline over the armpod (00:28).He then pressed that same blue pedal and applied energy for approximate one second (00:29).He then immediately moved his foot to the left blue pedal, and proceeded to begin clamping the stapler (00:29).After the stapler is clamped, he then presses the yellow pedal and begins the firing countdown.As the firing countdown is ongoing, some blood is present in the right side of the screen.The amount of blood increases as the stapler fires completely and unclamps successfully.While the stapler is unclamping, the surgeon moved the camera and picked up gauze and applied pressure to the assumed bleeding spot.The stapler is then removed by the bedside, and the surgeon lifted up the gauze from the bleeding spot to reveal damage to a vessel.The surgeon then proceeded to use gauze and suction (controlled by bedside) to control the bleeding.He then applied bipolar energy with the curved bipolar dissector to the bleeding spot.The same vessel then began to bleed from additional spots, and suction and gauze were used to apply pressure.The curved bipolar dissector is then used to apply energy to those new bleeding spots.Finally, the bedside exchanges the curved bipolar dissector for a mega suturecut needle driver, and brings in suture.The bleeding spots in the vessel are oversewn with suture, and then pressure is applied with gauze.Finally, a hemostatic agent is laid on top of the vessel, and the surgeon proceeds with his dissection as planned." 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.This complaint is being reported due to the following conclusion: during a da vinci-assisted right upper lobectomy surgical, the surgeon inadvertently activated the wrong pedal and grazed the chest wall with the cbd instrument.As a result, the patient experienced minimal bleeding which was addressed with the application of pressure, use of bipolar energy, and placement of sutures.However, the intra-operative complication can be attributed to use-error as the surgeon pressed the incorrect pedal while attempting to perform a surgical task with a stapler instrument.There is no allegation that a malfunction of an da vinci system, instrument, or accessory occurred.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Information for initial reporter name and address is not available.

Event Description

It was reported that during a da vinci-assisted right upper lobectomy surgical the surgeon placed the sureform 45 curved-tip stapler instrument with a white sureform 45 reload installed around the truncus artery.The surgeon was then ready to clamp and fire.The surgeon's right hand which had the curved bipolar dissector (cbd) instrument was out of the surgical view.When the surgeon went to clamp down with the stapler instrument, he inadvertently put his foot on the right blue pedal (for the cbd instrument) instead of the left blue pedal (for the stapler instrument), and activated the pedal for a short time.He immediately then moved his foot to the left blue pedal and clamped and fired the stapler instrument as intended.During the stapler countdown, blood from the right side of the screen was visible (likely where the cbd instrument was).After the stapler fire was completed, the surgeon moved the camera over to locate the source of the bleeding and noticed the bleeding was from tissue where the cbd instrument had made contact.The specific tissue that was injured was not disclosed.The surgeon was able to control the bleeding by applying pressure, using bipolar energy, and by oversewing the defect.The estimated blood loss was about 100 ml.The procedure was completed with no further issues.There was no blood transfusion rendered to the patient.Intuitive surgical, inc.(isi) contacted the surgeon and obtained the following additional information regarding the reported event: the surgeon stated that while manipulating lung tissue, the cbd instrument grazed the chest wall and there was slight bleeding.The bleeding was addressed with a suture.The estimated blood loss was less than 100 ml.The surgeon confirmed there was no isi device or system malfunction, and the intra-operative complication was inadvertent.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 14765934
• MDR Text Key: 294511427
• Report Number: 2955842-2022-12280
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380677-03
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• 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