MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number 480422-01

Device Problems Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 08/16/2023

Event Type  Death  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.The operation reportedly involved resection of a complex tumor located around branches of the pulmonary artery.The event occurred after the robotic procedure was completed; the report source indicated the event was not da vinci products related.Review of the da vinci system log found that there were no related errors that would likely have caused or contributed to the reported event either during this surgery or the procedure completed prior to this procedure.Log data for subsequent cases was not available as onsite is not updated frequently at this site.Review of the device history record found no non-conformances that would have caused or contributed to the reported event.Review of the device logs for the instruments used during the procedure found that with the exception of the permanent cautery spatula, the endoscope and all of the multi-use instruments were used in subsequent procedures.A site history review found that no complaints have been filed against any of the instruments or the endoscope.The only single-use device, the vessel sealer extend, was not used in any subsequent procedures and was presumed to have been discarded.The vessel sealer extend advanced log review found that the instrument was installed twice and passed homing each time.There were a total of 40 ¿cut complete¿ events and 46 ¿seal¿ events recorded with no errors.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that based on the available information, the patient was undergoing a resection of a tumor in the chest.The initial report states the tumor was embedded to pulmonary vasculature including the pulmonary artery.The details of how the tumor was excised and which instruments were used was not provided.However, the patient had a bleeding event in the immediate post-operative period after closure but before the patient had left the operating room.The patient did not survive an emergent and immediate open re-exploration.The findings of that re-exploration are unknown.Based on the information provided in the summary of events, insufficient information exists to determine if any intuitive surgical products or instruments contributed to this event.

Event Description

It was reported that a patient underwent a da vinci-assisted thoracic resection to excise a complex unspecified lung tumor that was embedded around the branches of the pulmonary artery.Information received from the report source was limited.At the conclusion of the procedure, when the patient was moved to a bed for transport, blood was observed in the chest tube.The patient was transferred back onto the operating table for an open re-operation to identify and stop the source of the bleeding.At an unspecified time during the open procedure, cardiac services were consulted for assistance.The open procedure lasted over 5 hours at which time the patient expired.The report source stated that the event was not da vinci related.Follow-up attempts to obtain additional information have been made; however, no further details have been provided.

Manufacturer Narrative

Section b5 additional information: it was clarified that the surgical procedure performed was a da vinci-assisted thymectomy.During the procedure, the vessel sealer extend (vse) instrument was used on unspecified veins.The surgeon suspected a venous bleed post-surgery and reported that it may have been related to the vse or something non-approach specific.The patient is believed to have expired due to the massive transfusion protocol (mtp) required and the "work flow" that occurred afterwards.Section d: based on this additional information, the suspect medical device information was updated to capture the vse instrument used during this procedure.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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: 17752495
• MDR Text Key: 323464563
• Report Number: 2955842-2023-18471
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: M10220828 0150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ISIFA2022-01-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 57 YR
• Patient Sex: Female