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

Model Number 380220-02

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 04/08/2019

Event Type  Injury  

Event Description

As part of a legal dispute, intuitive surgical, inc.(isi) received information regarding a patient who underwent a "partial nephrotic robotic laparoscopic procedure" on (b)(6)2019 who was readmitted to the hospital "four days after her surgery" on (b)(6) 2021 exhibiting post-operative symptoms of ¿regurgitated approximate 30 times during the previous nine hours"; vomiting "black coffee ground material that smelled of feces." a re-operation was performed to repair an "8mm hole" that had been ¿left by the arm of the trochar" causing the patient¿s bowel to become "herniated and strangulated." the patient was reported as stable and the patient was discharged.It was also alleged that a "broken machine" was not "adequately repaired" prior to the initial procedure on (b)(6) 2019.It was also alleged that during the initial procedure on (b)(6) 2019, there was a "need to convert to an open procedure," there were "additional or larger incisions," that there was ¿equipment failure," and there were "uncontrolled electrical currents" with "parts of the robot being left behind," and there were "tissue burns" due to "the surgeon not being in total control of the robot." the following additional information was obtained from new information contained within operative reports and progress notes that were supplied to isi on (b)(6) 2021: a (b)(6) female underwent a robotic-assisted laparoscopic left partial nephrectomy for removal of "an enlarging left lower pole mass, measuring approximately 2 cm in size" on (b)(6) 2019.Within the description of the procedure and operational detail, it was cited that "several areas of bleeding were noted posterior and along the lumbar posteriorly" for which 2-0 vicryl sutures were applied "to allow for compression of the bleeding and further dissection." additionally, it was noted: "the renal tumor in the lower pole was scored and then bulldog clamps were placed on the artery followed by the vein.The mass was excised in its entirety.Several small vessels extending to this mass in the lower pole were ligated using a 2-0 vicryl suture.The bed of the resection was also ran with the same suture.Cinching sutures as well as surgicel and floseal were placed in the cavity of dissection and then tightened.The clamp was taken off at that time.Renal clamp time was 26 minutes.The site was reapproximated over the surgicel using 0 vicryl suture and hem-o-lok.A drain was placed through a separate incision, which was a 10 mm round drain.The renal mass was placed in an endo catch bag and extracted from the abdomen at the umbilicus." the incision sites and extraction site were closed.The patient was awakened, extubated, and taken to recovery room in satisfactory condition.Estimated blood loss for the initial procedure was recorded as 250ml.Per the operative report, blood replacement and complications were noted as "none." she was discharged on postoperative day #1 or #2 without complications and a suction drain was placed at the left lower quadrant.On postoperative day #3, the patient reportedly "developed nausea, vomiting, and subjective fevers and chills." on postoperative day #4, the patient presented to the emergency room (er) with symptoms of "right flank pain" and "nausea, vomiting, and a white count of 14." a ct scan found evidence of a "herniation of bowel through left lower quadrant trocar site.On (b)(6) 2019, the patient underwent "exploration of left lower quadrant of abdominal wall" and "reduction of small bowel hernia and closure of fascia." operative findings included: "small bowel hernia of 8 mm, robotic trocar site on left lower quadrant.Bowel intact without any evidence of necrosis.Primary closure of the fascia performed." the estimated blood loss of the procedure was 10ml and no complications were noted.A 10 mm round drain was placed through the previous left lower quadrant.Per regulatory memo dated (b)(6) 2019, follow-up activities, including investigation that would require contacting the hospital, surgeon, and/or the patient related to the legal complaint will be performed by the legal department as part of the litigation process.The standard legal case will include grievance against the surgeon, hospital, and other involved parties making it impossible for the post market surveillance department to gain additional information about the event outside of this legal process.

Manufacturer Narrative

This event was initially reported on (b)(6) 2021 via mdr report #2955842-2021-11029 when the site name was unknown.A new/initial mdr was generated via a new complaint record under the identified hospital/site name that was included within additional information that was obtained on(b)(6) 2021.Based on the current information provided, the root cause of the operative complications cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.Site history review was conducted on (b)(6) 2021 and did not show any additional complaints related to this event other than the initially reported complaint record under an unknown site location.No image or video clip for the reported event was submitted for review.A review of the instrument logs was performed on (b)(6) 2021 for a procedure on (b)(6) 2019 on system us(b)(4) at 9:01 pm.All reusable instruments used in the case have been used in subsequent procedures through their respective end of uses and, at this time, a site history search shows no complaints filed against those instruments.System error log review was also conducted.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.Based on the information provided at this time, this complaint is reportable due to the following: the initial legal document alleged ¿parts of the robot being left behind.¿ it is unknown what ¿parts¿ were being described and it was unknown what was meant by ¿left behind.¿ additionally, it is unknown if all fragments were retrieved during the same procedure and it is unknown if additional surgical intervention was required due to the fragments.Unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what broke and what was ¿left behind¿ and it is also unknown what caused the breakage to occur.Further, the described event meets the criteria of a reportable adverse event.The legal initial document alleged the ¿need to convert to an open procedure, additional or larger incisions, increased potential for humans and machine error, equipment failure, uncontrolled electrical currents, parts of the robot being left behind, the surgeon not being in total control of the robot, and tissue burns¿, although the new information within the operative and progress notes did not indicate same.Additionally, a reoperation was required four days post-operatively to repair an alleged ¿8mm hole¿ that had been ¿left by the arm of the trochar¿ causing the patient¿s bowel to allegedly become ¿herniated and strangulated¿.Although isi received operative reports and progress notes which included an identified site name and additional event information, at this time, the root cause of the alleged postoperative complications remains unknown.Blank mdr fields" due to the nature of the complaint (litigation), follow-up could not performed to attempt to obtain additional patient-related information.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

• Brand Name: DA VINCI
• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12921615
• MDR Text Key: 286344696
• Report Number: 2955842-2021-11644
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380220-02
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2021
• 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.
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 77 KG