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

Model Number 380652-42

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Vascular Problem (4441)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.No product is expected to be returned for analysis as there was no allegation of a product issue.If additional information is received, a follow-up mdr will be submitted.Site complaint history review was conducted and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.System error log review was conducted on 14-aug-2021 for a procedure on (b)(6) 2021 on system sk2026.There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.While not all reusable instruments used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against those instruments.Based on the information on file at this time, this complaint is reportable due to the following: the site risk manager stated that there was ¿no suspicion¿ and there was no allegation of a da vinci product malfunction.It was reported by an isi clinical territory associate (cta) that the surgeon of record who performed the da vinci-assisted procedure was not a da vinci trained surgeon and it may have been the surgeon¿s first robotic case.However, the site risk manager stated that the console surgeon of record was robotic certified from michigan state university.According to a site history review, there was no initial support call identified and there were no observed events in the system logs that suggest a product issue.It was reported that all da vinci instruments were in the field of view and it was confirmed that no da vinci instrument caused or contributed to the event.There is no allegation or evidence of a product issue that would be classified as a malfunction.However, the described event meets the criteria of a reportable adverse event.The site risk manager attributed the cause of the bleeding event with blood transfusions and subsequent complications with reoperations to what was described as ¿surgical error¿ with use of the third party con-med v-care device; that ¿the force involved caused it all¿ and that it was an ¿accident that was unforeseeable and unexpected".It was also believed by the site risk manager that, according to a pathologist, ¿patient anatomy may have also been an issue¿.While there is no indication that the described surgeon error was related to a product problem, isi was unable to speak with the console surgeon of record and, at this time, it is unknown if use error was involved in this event.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was initially reported by the site robotics coordinator, via an intuitive surgical, inc.(isi) clinical territory associate (cta) that during a da vinci-assisted hysterectomy procedure on (b)(6) 2021, the operating room (or) staff stated that the patient had experienced a ¿complication due to either mis-use of the instrument or the v-care of the uterine manipulator and nicked the iliac artery¿.It was further reported that the procedure converted to open surgery to control bleeding and that, ¿two general surgeons took over and the patient had to have her leg amputated¿.The patient was allegedly originally going to be transferred to stanford to resolve the ¿complication¿ but due to unforeseen and unspecified ¿additional complications¿, possibly an unknown amount of ¿extensive bleeding¿, the patient stayed at the site of the initial procedure.On an unspecified date, the patient allegedly ¿had her leg amputated¿ and potentially had another operation and a blood transfusion.No other details were known or provided.It was reported that the surgeon who allegedly performed this procedure was not a da vinci trained surgeon and that it was believed to have been the surgeon¿s first robotic case.On 17-aug-2021, isi obtained the following additional information from the site quality/patient safety/risk management regarding the reported event from investigation findings, file review, interviews with surgical team members, and interviews with surgeons; including the console surgeon of record: during a da vinci-assisted hysterectomy procedure on (b)(6) 2021, a (b)(6) hispanic female experienced what was described as a ¿massive bleeding event¿.It was reported that at the ¿very end¿ of the case with ¿just a couple of minutes left in the surgery¿, the console surgeon of record inserted a third party ¿con-med v-care device¿ and it ¿punctured through the internal and external iliac vein¿ which resulted in ¿massive bleeding¿ and the procedure converted to open surgery.Two general surgeons and a vascular surgeon, ¿who were nearby¿, came into the operating room (or) to assist the console surgeon.It was reported that the third party con-med v-care device manually controls the uterus so that surgeons can complete a robotic procedure and that the device ¿controls the movements of the uterus up and down, side to side¿ so when the console surgeon moved the uterus up to work behind it to try and ¿cut the uterus from the cervix¿, the third party con-med v-care device movement ¿punctured right through the uterus and into or through the internal and external iliac vein¿ and that¿s when the surgeon saw ¿immediate extensive blood¿.The patient's estimated blood loss (ebl) was 2,000 ml for which 13 units of prbc, 10 units of plasma, 2 units of cryo, and 2 units of platelets were administered.The patient ¿went into dic¿, which was described as disseminated intravascular coagulation, due to ¿massive hemorrhage and blood loss¿.The patient was stabilized, the abdomen was ¿packed¿, and ¿everything was left to settle¿.A second exploratory reoperation was performed on (b)(6) 2021 by a vascular surgeon who reported that the patient's left lower extremity blood flow was compromised in the process of the vascular injury and the bleeding event and also reported that there was ¿irreparable vein damage¿, the patient was ¿unstable¿, and the patient's left leg was amputated ¿in order to save the patient¿s life¿.A third reoperation was performed on (b)(6) 2021 for ¿abdominal re-exploration repair and closure¿.The patient was extubated on (b)(6)2021 and was ¿more alert¿.As of (b)(6) 2021 the patient was still in the critical care unit but had stabilized and was expected to be transferred.Isi has reached out to the surgeon of record to obtain additional information but has not yet received a response.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12431144
• MDR Text Key: 270054371
• Report Number: 2955842-2021-11086
• 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: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-42
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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: 54 YR