MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-51

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Sepsis (2067)

Event Date 12/10/2021

Event Type  Death  

Event Description

It was initially reported that during a da vinci-assisted unilateral inguinal hernia procedure that the patient experienced an unknown complication and later passed away due to unknown means.Intuitive surgical inc.(isi) contacted the surgeon of this procedure and additional information was obtained about the complaint: the surgeon said the patient¿s death has nothing to do with a da vinci product as the patient died of sepsis due to their colon dying six days after the da vinci-assisted bilateral hernia repair.The surgeon performed an emergency exploratory procedure when the patient returned to the hospital with abdominal pain and signs of dehydration.During this exploratory procedure, the surgeon found the patient¿s colon had died from the inside and there was no evidence of any external injuries to the patient¿s intestines or colon.The surgeon removed the patient¿s entire colon to resolve this event, but the patient was already septic and passed-away.The surgeon believes the patient¿s colon became ischemic possibly due to a blood clot or it becoming distended.The surgeon clarified that the ultimate reason for the patient¿s colon dying is currently unknown as the autopsy is not complete.The surgeon said they are not able to provide the autopsy report due to their hospital regulations.The patient¿s colon was observed by a pathologist who reported that the colon had colitis.The surgeon reported that they did not touch the patient¿s intestines at all during the da vinci-assisted procedure and they think the patient death was caused by their anatomy and/or medical history.The surgeon said the patient had a history of deep vein thrombosis and was on blood thinners.

Manufacturer Narrative

Based on the information provided, the cause of the reported complication has been determined by the console surgeon to be related to the patient¿s pre-existing medical condition.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Therefore, no product is expected to be returned.A follow-up mdr will be submitted if additional information is obtained.A medical review was performed by an isi medical safety officer and the following information was provided: "based upon the information in the description of events, the patient developed an ischemic colon shortly after undergoing a da vinci-assisted bilateral inguinal hernia repair which led to the patient¿s death.The reason for the colonic ischemia is unknown." an isi technical support engineer (tse) reviewed the system logs for this procedure on (b)(6) 2021 and provided the following information: 21 procedures have been performed on system sk4941 from the event date to (b)(6) 2022 with no reported complaints.During the procedure on (b)(6) 2021, there were no significant errors.As a result, the tse did not recommend for a field service engineer (fse) to visit the site to perform system verification testing.The customer has not created any service requests since this reported event.A review of the instruments logs for the procedure date of (b)(6) 2021 has been performed by a post market surveillance specialist and the following was observed: all multi-use instruments used in the case have been used in subsequent procedures with the exception of the single-use instruments and the following instruments: force bipolar (part number: 470405-06/ lot number: n10200127-0244/uses remaining: 3), monopolar curved scissors (part #470179-19, lot #k10210705-0061, uses remaining: 0).No image or video clip for the reported event was submitted for review.A review of the site's complaint history was performed and no other complaints related to this event were identified.This event is being reported due to the following conclusion: a patient underwent a da vinci-assisted unilateral inguinal hernia procedure and returned to the hospital six days post-operatively.The patient received a secondary procedure where the patient¿s colon was removed due to colitis.However, the patient ultimately expired.The cause of the patient's post-operative complication is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Follow-up was attempted, but the missing patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is blank because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 13286202
• MDR Text Key: 283999035
• Report Number: 2955842-2022-10097
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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: 12/20/2021

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: 380652-51
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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: 76 YR
• Patient Race: Black Or African American