MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CADIERE FORCEPS

Model Number 470049-06

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Injury (2348); Multiple Organ Failure (3261)

Event Date 05/10/2019

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, isi has not determined the root causes of the patient¿s post-operative complications and subsequent demise.There is no allegation that a malfunction of a da vinci surgical system, instrument, or accessory occurred.The cadiere forceps instrument involved with the reported event is not available for isi to evaluate.If additional information is received, a follow-up mdr will be submitted.Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2019.No related system errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted pulmonary lobectomy procedure, the patient experienced an ¿acute type b aortic dissection¿ and subsequently expired.However, the root causes of the patient¿s post-operative complications and subsequent death are unknown.

Event Description

It was reported that after undergoing a da vinci-assisted pulmonary lobectomy procedure, the patient experienced an ¿acute type b aortic dissection.¿ the surgeon suspected that the cause of the vessel complication was a cadiere forceps instrument that had allegedly made contact with the vessel.On (b)(4) 2019, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: there was no report that a malfunction of a da vinci system, instrument, or accessory occurred during the da vinci-assisted surgical procedure which was performed on (b)(6) 2019.Right after the surgical procedure was completed, the patient complained of abdominal and back pain.At that time, medical staff initially thought the issue was related to body positioning.However, the following day, the patient still had complaints of pain and an epidural was then administered.On (b)(6) 2019, a contrast-enhanced ct scan was conducted and a type b aortic dissection was diagnosed.The patient was started on anti-hypertensive agents for blood pressure control.In addition, an oxygen mask was administered after the patient had reports of respiratory distress.Pleural effusion was also observed and thoracentesis was performed.On (b)(6) 2019, an exploratory laparotomy was performed and a pale liver was observed from extensive small intestinal necrosis centering on the area of the superior mesenteric artery (sma) and ¿ischemia of the peritoneal cavity artery region.¿ necrotic tissue of the small intestine was resected via open surgery.On (b)(6) 2019, the patient underwent additional open surgery and a right hemicolectomy was performed.After surgery, the patient¿s blood pressure dropped.The patient was conscious at the time and continuous infusion of bosmin was administered.On (b)(6) 2019, the patient lost consciousness, her heart rate rapidly dropped, and then she suffered cardiac arrest.Heart massages were administered; however, the patient expired that same day.The cause of death was noted as ¿multi-organ ischemia and multi-organ failure caused by decreased blood flow due to aortic dissection.¿ the site indicated that a cadiere forceps instrument was in contact with the aorta several times during the surgical procedure.Therefore, the site believed that the cadiere forceps instrument had possibly caused the type b aortic dissection although there was no allegation that a malfunction of the instrument had occurred.The cadiere forceps instrument is not available for return to isi for evaluation.The surgeon commented, ¿aortic compression by the number 4 arm during #7 removal is considered the cause, but the largest factor was lack of awareness of risk in the preliminary stage.¿.

Manufacturer Narrative

Intuitive surgical, inc.(isi) obtained video clips of the surgical procedure involved with this complaint.The video clips were reviewed by isi clinical development engineering and the following analysis was provided: in two video clips, there are surgical tasks being performed under the aortic arch to dissect lymph nodes.In 2 to 3 instances, it was observed that a cadiere forceps instrument was being used to move the aorta to expose the surgical view.Additionally, in 2 to 3 instances of one video clip, there appears to be imprecise monopolar cautery application which resulted in burns to the aorta.The root cause of the aortic dissection could not be determined from a review of the video clips.Based on the current information provided, this complaint will remain reportable due to the following conclusion: after undergoing a da vinci-assisted pulmonary lobectomy procedure, the patient experienced an ¿acute type b aortic dissection¿ and subsequently expired.However, the root causes of the patient¿s post-operative complication and subsequent death are still unknown.

Manufacturer Narrative

Additional information can be found in sections g4, g7, h2, and h10.On(b)(6)2020 , intuitive surgical, inc.(isi) obtained the procedure note of the surgical procedure associated with this complaint.A review of procedure note revealed no reports of a device malfunction.It was noted that after the left lower lobe was removed, residual lymph nodes under the tracheal branch were also removed.A leak test was performed and no obvious air leaks were identified.After the leak test was performed the following was noted: ¿after confirming that bleeding had stopped, rolling out of the patient cart was conducted.A 24fr double lumen trocar was retained at the backside of the chest cavity from the small incision hole of the eighth intercostal space in order to close the incision and the surgery was completed.¿ it was further noted that there were abundant lymph nodes that were slightly difficult to remove.There were no reports of any intra-operative complication.Based on the current information provided, this complaint will remain reportable due to the following conclusion: after undergoing a da vinci-assisted pulmonary lobectomy procedure, the patient experienced an ¿acute type b aortic dissection¿ and subsequently expired.However, the root causes of the patient¿s post-operative complication and subsequent death are still unknown.This supplemental report, with additional information collected, is in response to fda inspectional observations dated (b)(6)2020.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: CADIERE FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8660706
• MDR Text Key: 146775316
• Report Number: 2955842-2019-10391
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K150284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470049-06
• Device Lot Number: N10190130-0036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 67 YR