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

Model Number 380652-49

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

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

There was no report or allegation from the customer of a 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." a review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.Although none of the reusable instruments with the exception of the endoscope were reused in subsequent procedures, a site review shows no complaint filed against these instruments.No image or video clip for the reported event was submitted for review.The logs were reviewed by an isi advanced failure analysis (afa) engineer and the following findings were observed: all of the errors in the logs for that procedure are class 0 (system service advisory (no fault reaction)) and class 8 (engineering event informational (no fault reaction)) so none of these would suggest a product issue.Error 100 seen in the logs indicates that a setup joint (suj) moved without being clutched.It would most likely just be caused by the customer moving the suj without clutching first.Additionally, there are no other errors along with this that suggest the suj moved on its own.Based on the information provided, this complaint is reportable due to the following: during a da vinci-assisted surgical procedure, the surgeon accidentally lacerated the pulmonary artery with a maryland bipolar forceps instrument during the dissection of the hilar lymph nodes and the procedure was converted to open in order to control the bleeding with staples.Additionally, the patient received a blood transfusion due to the blood loss.There is currently no allegation of a malfunction of a da vinci system, instrument or accessory.There was no non-intuitive motion of instrument or arms.The surgeon attributed the issue to difficult anatomy, whereby the lymph node was lying very close to the pulmonary artery with not much space in between.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.

Event Description

It was reported by the intuitive surgical, inc.(isi) clinical sales representative (csr) that during a da vinci-assisted pulmonary lobectomy procedure, the surgeon finished taking down the right pulmonary lobe.During the lymph node resection by the pulmonary artery, the surgeon accidentally lacerated the pulmonary artery.Attempts to control the bleeding robotically were unsuccessful and the procedure was converted to open surgery.Isi followed up with distributor who spoke to the surgeon and obtained the following information: the name of the procedure was right lobectomy, in which the surgeon removed the upper lobe and half of the middle lobe of the right lung.The instruments and system were inspected before use and there was nothing out of the ordinary.The surgeon was trying to dissect the hilar lymph node which was lying next to the pulmonary artery.The anatomy was "compromised" from the beginning in which the doctor could not differentiate the depth of the nodule.The artery was too close to the lymph node and there was not much space in between.The maryland bipolar forceps lacerated the artery.The injury was not due to surgical technique, non-intuitive motion of the instruments or system arms.There was no collision or bumps externally which led to the pulmonary artery injury.The anatomy was "too compromised" and led to the injury.The bedside assist tried using a third-party stapler instrument to stop the bleeding but could not reach the location of injury and thus, the procedure was converted to open and the bleeding was secured with staples.The blood lost from the pulmonary artery was 700 ml and the patient was transfused with 200 ml of blood.The patient did not require admission to the icu and was discharged from the hospital 3 days after the procedure.

• 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: 12579616
• MDR Text Key: 275857906
• Report Number: 2955842-2021-11256
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-49
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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 Age: 47 YR
• Patient Weight: 45