MAUDE Adverse Event Report: DAVINCI SURGICAL SYSTEM

Model Number N/A

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

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Death  

Manufacturer Narrative

There was no initial report or allegation from the journal article author, or any known allegation from a medical professional, of a specific deficiency of the da vinci system, instrumentation or accessories associated with the reported incident.Therefore, there are no products expected for return to intuitive surgical, inc.(isi) for failure analysis evaluation.Based on the current information provided, the root cause of the operative complication cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was unable to be conducted as the procedure date was unknown & site is unconfirmed.Unable to conduct system or instrument log review due to lack of site, system, procedure, and instrument detail.No image or video recording is available for review.A review of the event was conducted by an isi medical safety officer and the following additional information was provided: the adverse event described is not unique to an isi product or procedure; however, there is insufficient to indicate an isi product caused or contributed to the adverse event.Based upon a review of the article, 46 patients underwent a robotic colon resection.Inclusion criteria was as follows: histological proven adnenocarcinoma of colon or upper rectum (> 10 cm from the anal verge).No previous or concurrent malignancy at any other site.No evidence of distant metastasis at the time of surgery surgical technique was as follows: full mechanical bowel preparation for all left sided lesions.Four 8 mm robotic ports were placed diagonally.Configuration ¿ two left-handed instruments and one right-handed instrument.Additionally, 3rd party 12 mm port placed for the assistant at the patient bedside.Primary vascular control for both the left and right sided colectomies was via a high-tie of the appropriate vessels.Medial to lateral dissection performed.After bowel resection, intracorporeal anastomosis was fashioned via a double-staple technique or a circular stapler.Resected bowel was extracted through a small pfannenstiel incision.Of the 46 patients in the robotic group, there were no anastomotic leaks, no procedure conversion from minimally invasive to an open procedure, and no blood transfusion.However, one patient in the robotic group died due to acute thrombosis of the superior mesenteric artery and the celiac axis.It is unclear from the information provided in the study as to the cause of the thrombosis.For comparison, there were a three anastomotic leaks laparoscopic group of 37 subjects.One patient in the laparoscopic group died due to septic shock from an anastomotic leak.Based on the information provided at this time, this complaint is reportable due to the following: isi became aware of a radiology and oncology article titled, ¿robotic versus laparoscopic surgery for colorectal cancer: a case-control study".In a robotic group, it was reported that a patient died due to an acute thrombosis of superior mesenteric artery and coeliac axis.Although there was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, and no instruments were returned for evaluation, based on the information available, the cause of the patient's operative complication and death is unknown.

Event Description

On 01-sep-2021, intuitive surgical, inc.(isi) became aware of a radiology and oncology article titled, ¿robotic versus laparoscopic surgery for colorectal cancer: a case-control study".In a robotic group, it was reported that a patient died due to an acute thrombosis of superior mesenteric artery and coeliac axis.Although there was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, and no instruments were returned for evaluation, based on the information available, the cause of the patient`s death is unknown.Isi has reached out to the author to obtain additional information but has not yet received a response.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

On (b)(6) 2021, the distributor reached out the hospital and, as a first analysis, the hospital confirmed the system was not directly involved in the issue and they need more time to be able to collect the required information.No further details have been provided as of the date of this report.

• Brand Name: DAVINCI SURGICAL SYSTEM
• Type of Device: DAVINCI SURGICAL SYSTEM
• MDR Report Key: 12558437
• MDR Text Key: 274200704
• Report Number: 2955842-2021-11224
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• 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.