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| Model Number 380940-40 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abscess (1690); Obstruction/Occlusion (2422)
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| Event Date 07/02/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Leak rates from colorectal anastomosis vary between 6 to 30% based on different risk factors and varying definitions of anastomotic leak.1 failure of colorectal anastomosis can lead to dire consequences such as prolonged hospitalizations, additional interventions, and increased morbidity and mortality.2 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.3 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.4 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.5 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.6 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 2015 jan 30.Pmid: 25633276.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 was noted to have high ileostomy output on post-operative day (pod) 2 ((b)(6) 2021) and pod 3 ((b)(6) 2021).On pod 4 ((b)(6) 2021), the subject had sudden onset of nausea and vomiting.On pod 5 ((b)(6) 2021), symptoms of ileus/small bowel obstruction including food aversion and reflux were noted and his abdomen was slightly distended.A ct scan was performed on pod 5 which identified a potential closed loop obstruction.The imaging also showed a moderate size presacral abscess.Reoperation was performed on pod 5.Once open, the small bowel injury was repaired, adhesiolysis was performed and a drain was placed into the pelvis.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 fda under ide annual progress report (g200060 / r002).
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Event Description
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Subject 600-02 (hereafter referred to as the subject) underwent robotic-assisted lower anterior resection with the da vinci sp surgical system on (b)(6) 2021.On (b)(6) 2021, the subject met all study eligibility criteria and signed the informed consent.The sp system was docked after creation of the sp port and the ileostomy port.Once the rectum was transected with the laparoscopic stapler, the specimen was delivered through the wound protecting device in the sp port.This was then resected and a prolene purse string was utilized to enter the anvil into the descending colon.After this was secured and replaced back into the abdomen, the abdomen was reinsufflated with the sp robotic device and the anastomosis was created.Proctoscopic and finger examination of the anastomosis revealed this to be intact.A section of the terminal ileum was identified near the cecum for the diverting loop ileostomy which was pulled through the ileostomy site.The sp port was removed, the site was then closed, no drains were placed.The ileostomy was then created.The subject did not experience any intraoperative complications, and there was no conversion to open surgery, robotic multiport or laparoscopic procedures.The subject was noted to have high ileostomy output on post-operative day (pod) 2 ((b)(6) 2021) and pod 3 ((b)(6) 2021).On pod 4 ((b)(6) 2021), the subject had sudden onset of nausea and vomiting.On pod 5 ((b)(6) 2021), symptoms of ileus/small bowel obstruction including food aversion and reflux were noted and his abdomen was slightly distended.A ct scan was performed on pod 5 which identified a potential closed loop obstruction.The imaging also showed a moderate size presacral abscess.Reoperation was performed on pod 5.The procedure was initiated as a laparoscopic procedure but was then converted to open due to an enterotomy in the small bowel.Once open, the small bowel injury was repaired, adhesiolysis was performed and a drain was placed into the pelvis.During the open procedure, flexible sigmoidoscopy of the rectal anastomosis was performed.The anastomosis was intact, and the pelvis was also evaluated with no evidence of purulence or debris.There were no intraoperative complications and the bowel obstruction resolved following this procedure.The subject was deemed stable and discharged on pod 11 ((b)(6) 2021).The subject had experienced no further aes per 42-day follow up on (b)(6) 2021.The study investigator classified the primary ae of bowel obstruction with onset on (b)(6) 2021 and resolution on (b)(6) 2021 as an sae possibly related to the lar procedure and not related to the study device and the underlying disease.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) received additional source notes for post operative day (pod) 1 ((b)(6)2021) to pod 4 ((b)(6)2021) on this subject: the procedure indication was for malignant tumor (adenocarcinoma), the subject had an intracorporeal approach anastomosis, end to end single stapled using a laparoscopic circular stapler, the subject had a diverting ileostomy which was planned and due to the perioperative chemo and radiotherapy.Based on the investigator, the da vinci sp surgical system was not used to identify the loop of the ileum and position the loop in alignment for the ileostomy.The ileostomy was brought out with the accessory trocar (covidien port) and a laparoscopic babcock in the ileostomy site of the right lower quadrant.The bowel was run from a combination of the accessory port along with visualization through the ileostomy site, not by the sp system.The camera of the sp system provided visualization.Per the investigator, there was no abscess identified during the exploratory laparotomy, there was only an adhesive obstruction at the level of the right side of the abdomen at the pelvic brim.The investigator has classified this as an obstruction but not a ¿closed loop.¿ the operative report of the exploratory laparotomy stated that the small bowel just proximal to the ileostomy was adhesed to some of the previous dissection and was quite narrowed and kinked, causing an obstruction.The pelvis was evaluated with no evidence of purulence or debris, which supported the investigator¿s explanation of no abscess.Per the investigator, operation finding by the surgeon prevails ct scan as the image may not always be reliable.The investigator clarified that the bowel obstruction is unrelated to the ileostomy.The event of obstruction is secondary to the fact that the patient had an operative procedure and was related to adhesion formation.This was not a technical issue nor was it preventable based on any technique known to surgery.The reported bowel obstruction was not related to the da vinci sp surgical system.
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Event Description
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Refer to h10/h11 for follow-up information.
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Manufacturer Narrative
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Approximate a month later after the initial da vinci assisted surgery, the patient was seen for wound healing, and non-healing fatty tissue was observed.Silver nitrate was applied to the wound and covered with gauze.Nine days later, the patient was confirmed with no signs of infection and continued his chemotherapy as scheduled.Approximate seven months later, a non-robotic ileostomy takedown was performed on (b)(6) 2022, where inflammation was noted, but anastomosis was noted to be normal.The patient tolerated the procedure well and was discharged the same day.Two days after, the patient presented at the emergency room (er) with persistent abdominal pain, nausea, vomiting.Computed tomography (ct) showed small bowel obstruction with transition point in the distal ileum near the site of the interval area ostomy takedown.The patient underwent an exploratory laparotomy on (b)(6) 2022 due to the small bowel obstruction.The small bowel was noted to be dilated.The entire small bowel from the ligament of treitz to the cecum was adhered together.The small bowel anastomosis was resected and was revised with a side-to-side functional end anastomosis.The patient recovered from the surgery without other complications.
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Event Description
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Refer to h10/h11 for follow-up information.
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Search Alerts/Recalls
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