MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; PATIENT SIDE CART

Model Number 380601

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

Patient Problems Fever (1858); Renal Failure (2041)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Leak rates from colorectal anastomosis vary between 6 to 30% based on different risk factors and varying definitions of anastomotic leak.Failure of colorectal anastomosis can lead to dire consequences such as prolonged hospitalizations, additional interventions, and increased morbidity and mortality.The most consistent determinant of a colorectal anastomotic leak is the anastomotic location.Initially, the connection of the colorectal anastomosis must be maintained by the chosen surgical technique because no strength comes from tissue healing.Regardless of the chosen technique, the principles of a proper anastomosis, a tension-free approximation of healthy, well-perfused unobstructed bowel, need to be followed to minimize the potential for a leak.The more distal the anastomosis, the higher the likelihood of failure, with resection of a distal rectal cancer having almost a five-fold increased risk of anastomotic leak comparted with resection for colon cancer.Colorectal anastomosis located within 6 cm of the anal verge are very likely to leak.Diverting ileostomies are typically created to protect the distal colorectal anastomosis to decrease the risk of anastomotic leak and the need for an urgent reoperation.Ileostomies are technically rather easy to create and are intended to be reversed after the colorectal anastomosis has healed (typically 3 to 6 months after the primary procedure).However, diverting ileostomies can be associated with postoperative morbidity that can reduce the patient¿s quality of life during recovery.Dehydration and stoma complications are common.Closure of a loop ileostomy is a relatively simple procedure.Postoperative complications such as bowel obstruction, wound infection, peritonitis due to anastomotic leak from the closure of the loop ileostomy, intra-abdominal abscess, anastomotic leak from the closure of the loop ileostomy with enterocutaneous fistula, and bleeding can occur.The most common complication of the loop ileostomy closure is bowel obstruction.References: peel al, taylor ew; surgical infection study group.Proposed definitions for the audit of postoperative infection: a discussion paper.Ann r collsurgengl 1991;73(6):385¿388 nt.Dietz ua, debus es.Intestinal anastomoses prior to 1882; a legacy of ingenuity, persistence, and research form a foundation for modern gastrointestinal surgery.World j surg 2005;29(3):396¿401.Mirnezami a, mirnezami r, chandrakumaran k, sasapu k, sagar p, finan p.Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis.Ann surg 2011;253(5):890¿899.Hanna mh, vinci a, pigazzi a.Diverting ileostomy in colorectal surgery: when is it necessary? langenbecks arch surg.2015 feb;400(2):145-52.Doi: 10.1007/s00423-015-1275-1.Epub (b)(6) 2015 jan 30.Pmid: (b)(4).Nhs, https://www.Nhs.Uk/ conditions/ileostomy/risks.Poskus e, kildusis e, smolskas e, ambrazevicius m, strupas k: complications after loop ileostomy closure: a retrospective analysis of 132 patients.Viszeralmedizin 2014;30:276-280.Doi: 10.1159/000366218.This complaint is being reported due to the following conclusion: after a da vinci-assisted low anterior resection, it was reported that the patient/study subject developed fever and hypotension on pod 2 following which he was started on intravenous antibiotics (ertapenem) and iv fluids.The subject¿s antihypertensive medication was paused.On pod 3 ((b)(6) 2021), the fever and hypotension were noted to have improved.On the same day, the subject developed vomiting and was diagnosed with ileus.Subsequently a nasogastric tube was placed.On the following day (pod 4, (b)(6) 2021), high ostomy output was noted.The nasogastric tube was removed on pod 6 ((b)(6) 2021).On pod 7 ((b)(6) 2021), the subject tolerated a soft diet, and the ileus was reported as resolved.He was discharged to home on the same day (pod 7).During follow up on (b)(6) 2021, the subject reported poor appetite, nausea, progressive weakness, and decreased urine output.The lab reports demonstrated acute renal failure and he was admitted for the same.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.At this time, the cause of the post-operative complications is unknown.This event has been submitted to the fda under ide annual progress report ((b)(4).Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.Blank because insufficient product information was provided in order to obtain the date of manufacture.

Event Description

On (b)(6) 2021, the subject (b)(4) underwent robot-assisted ultra-low anterior resection with periaortic lymph node dissection, total mesorectal excision, primary low pelvic coloanal anastomosis using the da vinci sp surgical system and laparoscopic diverting loop ileostomy.On (b)(6) 2021, the subject met all study eligibility criteria and signed the informed consent.The subject had very difficult anatomy in part due to the previous staged procedure and the location of the lesion in the low rectum.After obtaining single port access, the port was placed, robot was docked, and an additional 12 mm port was placed in the right quadrant.Perioaortic lymph node dissection was performed.The specimen was extracorporealized by undocking the da vinci sp system using the wound retractor placed at the umbilicus.The anvil was then secured to the circular lap stapler (size 29) with a purse string suture.The da vinci sp system was then re-docked, pneumoperitoneum was reestablished and a low pelvic coloanal anastomosis was created which was intact and tension-free.The doughnuts were checked and were intact.The air insufflation test also revealed no bubbles or leaks.At this juncture, the terminal ileum was identified and marked proximal and distal.The terminal ileum was then brought out through the predetermined ileostomy site on the right and then the ileostomy was pulled up in an oriented fashion.The robot was then undocked, the port site was closed, and the ileostomy was matured in a brooke fashion using vicryl sutures.The subject did not experience any intraoperative complications, and there was no conversion to open surgery, robotic multiport or laparoscopic procedures.The subject tolerated the procedure well and postoperative pain was well controlled.The postoperative diagnosis was adenocarcinoma of the low rectum.The ileostomy was noted to be functioning on pod 1 (b)(6) 2021).The subject developed fever and hypotension on pod 2 following which he was started on intravenous antibiotics (ertapenem) and iv fluids.The subject¿s antihypertensive medication was paused.On pod 3 ((b)(6) 2021), the fever and hypotension were noted to have improved.On the same day, the subject developed vomiting and was diagnosed with ileus.Subsequently a nasogastric tube was placed.On the following day (pod 4, (b)(6) 2021), high ostomy output was noted.The nasogastric tube was removed on pod 6 ((b)(6) 2021).On pod 7 ((b)(6) 2021), the subject tolerated a soft diet, and the ileus was reported as resolved.He was discharged to home on the same day (pod 7).During follow up on (b)(6) 2021, the subject reported poor appetite, nausea, progressive weakness, and decreased urine output.The lab reports demonstrated acute renal failure and he was admitted for the same.It was also noted that he did not have excessive ileostomy output.The subject was clinically dehydrated on admission.He was treated with iv bicarbonate infusion.The renal ultrasound was unremarkable and aggressive hydration resulted in normalization of his renal function.His appetite also improved, and he tolerated his diet well.The adverse event of acute renal failure was resolved, and the subject was discharged to home on (b)(6) 2021.The study investigator classified the primary ae of ileus as a serious adverse event (sae) with (b)(6) 2021 as the date of onset with resolution on (b)(6) 2021.The investigator reported the sae as definitely related to the lar procedure and the underlying disease, and not related to the study device.The dsm classified the primary ae of ileus as a sae with (b)(6) 2021 as the date of onset with resolution on (b)(6) 2021.The dsm reported the sae as definitely related to the lar procedure and not related to the study device or the underlying disease.The study investigator classified the primary ae of acute renal failure as a serious adverse event sae with (b)(6) 2021 as the date of onset with resolution on (b)(6) 2021.The investigator reported the sae as definitely related to the lar procedure and the underlying disease, and not related to the study device.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following fields: g3, g6, h2, and h10.Intuitive surgical, inc.(isi) received additional information regarding the study ¿ the procedure indication was for malignant tumor (adenocarcinoma), the subject had an extracorporeal approach anastomosis, end to end single layer using a laparoscopic circular stapler, the subject had a diverting ileostomy which was performed for 2 reasons: 1) due to the low nature of the anastomoses and 2) due to the distorted anatomy and effects of the first stage procedure which was a transanal excision.This was planned as a very likely possibility prior to surgery, but the decision was made based on the intraoperative findings in anatomy.The patient had been marked preoperatively and consented for an ileostomy specifically because this was a second-stage procedure and, in these cases, often the anatomy is distorted and thickened and therefore higher risk of anastomotic dehiscence.The ileostomy however was not due to technical difficulties.It was due to the inherent nature of the procedure and existing anatomy.In this subject, the investigator confirmed that an abdominal ct was not performed.The investigator provided further clarification that the renal ultrasound was not clinically significant and did not warrant follow-up with an abdominal ct.

• Brand Name: DA VINCI SP
• Type of Device: PATIENT SIDE CART
• 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: 14063913
• MDR Text Key: 294497768
• Report Number: 2955842-2022-10961
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380601
• Device Catalogue Number: 380601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2022
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White