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

Model Number 380652-35

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 10/29/2020

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.If additional information is received, a follow-up mdr will be submitted.Site history review was conducted on 3-nov-2020 and again on 10-nov-2020 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.While emergency stop (e-stop) was recorded as pressed by a user, 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 performed.While none of the reusable instruments used in the case have been used in subsequent procedures at this time, except for endoscope pn: 470026-65 || ln: sf00001923-789, a site history search shows no complaints filed against the instruments.Logs reflect two cadiere forceps instruments in use during this procedure.An isi clinical development engineer (cde) conducted review; results were as follows: the description reads like due to the hardened lymph node the surgeon had to modify his/her technique, and the hardened lymph node increased the difficultly of the surgery.The surgeon stated, ¿difficult to dissect and get around, even during open procedure.¿ this statement highlights the challenging patient anatomy regardless of surgical modality.There is not necessarily direct correlation between hardened lymph nodes and vessel puncture but it may be a contributing factor, and it may have increased the overall difficulty level of the procedure.Based on the information provided at this time, this complaint is reportable due to the following: while there was no allegation that the intra-operative complication occurred due to use of an isi product and the surgeon allegedly attributed the cause of the issue to patient anatomy and hardened lymph nodes, the described injury and medical intervention meets the criteria of a reportable event.Specifically, there was placement of a clip, suture, staple, or other intervention that was not planned, that was required to control bleeding of a vascular structure.Additionally, the root cause of the intra-operative bleeding cannot be determined.

Event Description

It was initially reported that during a da vinci-assisted pulmonary lobectomy procedure, the surgeon struck the pulmonary artery (pa) with a long bipolar grasper instrument resulting in an unspecified amount of bleeding.The surgeon converted the procedure to a thoracotomy where the pa was clamped with a cadiere forceps instrument to pull the proximal end closed and a clamp was used to close the distal part of the pa.At that point, the surgeon removed all arms except for the cadiere forceps instrument.Once the surgeon had access to the proximal end of the pa with the cadiere forceps, they unlocked the cadiere forceps with the instrument release kit (irk) and successfully removed the instrument.Intuitive surgical, inc.(isi) followed up with the isi clinical territory associate (cta), who was present during the procedure, and obtained additional information.It was reported that during a da vinci-assisted pulmonary lobectomy procedure, the surgeon had dissected a few lymph nodes.The surgeon made his way into the interior portion of the dissection which is when the surgeon punctured the pulmonary artery (pa) with the tip of a long bipolar grasper instrument.This resulted in 100-200 ml of bleeding from a 2-3cm size puncture area.No blood transfusion was required as the surgeon reportedly, ¿grabbed the artery right away with a cadiere forceps instrument to stop the bleeding¿ and the procedure converted to an open thoracotomy surgery.The surgeon, ¿completely undocked with only the cadiere forceps remaining¿.The pa was then clamped.The cadiere forceps instrument was successfully removed from the pa with use of an instrument release kit (irk).During the open thoracotomy, the surgeon repaired the pa vessel by stapling both the proximal and distal end of the pa.The thoracotomy procedure completed with no report of patient harm or injury.The patient is reported as stable with no report of post-operative complications.The cadiere instrument will be returned to isi, ¿but only because it had expired and the irk was used on it¿.It was reported that the surgeon believes that the cause of the issue was that the patient had, ¿adenocarcinoma, 3a and the lymph node was hardened under the pa, making it difficult to dissect and get around, even during open procedure." the cause was attributed by the surgeon as being patient anatomy and hardened lymph nodes.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10887047
• MDR Text Key: 218516588
• Report Number: 2955842-2020-11246
• 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: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-35
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• 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
• Patient Outcome(s): Other