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

Model Number 480422-01

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Vascular Problem (4441); Unspecified Tissue Injury (4559)

Event Date 08/04/2021

Event Type  Death  

Manufacturer Narrative

According to the hospital's administration, the cause of the intra-operative complications resulting in patient death can be attributed to ¿surgical error; surgeon related.¿ the site reported that the event was due to ¿surgeon error¿ and that ¿no robot issues caused this event.¿ however, the root cause of the customer reported complication and subsequent death cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was conducted and did not show any additional complaints related to this event/for this product.No image or video clip for the reported event was submitted for review.A system error log review was conducted on 05-aug-2021 for a procedure on (b)(6) 2021 on system (b)(4).There were no observed events in the system logs that would suggest a product issue during 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.An isi advanced failure analyst (afa) engineer conducted a vessel sealer log review and found that at approximately one hour and forty minutes into vessel sealer extend (part #480422-01, lot #m90210504-0041) usage, there were two ¿vs_jaw_angle_open¿ messages which indicate that the instrument jaw was too far open to allow cutting.This likely indicates that the surgeon was grasping too much or thick tissue which left the jaw angle open too far to allow cutting.The logs were free of any error or behavior suggestive of an instrument issue.A review of the event information provided was conducted by an isi medical safety officer and the following was noted: ¿the surgeon, while performing a da vinci-assisted esophagectomy, injured an un-named blood vessel leading to hemorrhage.The surgeon was unable to control the bleeding resulting in a reactive conversion to an open thoracotomy.The site hospital administration indicated that patient expired due to the cardiac arrest resulting from acute blood loss anemia.The site hospital administration further indicated that the surgeon inadvertently mis-identified the anatomy.Based upon the information in the description of events, the event was due to anatomical misidentification which is considered a user error.¿ during a da vinci assisted non-transthoracic esophagectomy procedure, the surgeon nicked a vessel when using the vessel sealer extend to ligate an unspecified vessel.The patient experienced an unspecified amount of blood loss and the case was converted to open.Resuscitation efforts were performed but were unsuccessful and the patient expired.This mdr is being submitted as part of a retrospective complaint review.

Event Description

It was initially reported that three hours into a da vinci assisted non-transthoracic esophagectomy procedure on (b)(6) 2021, a (b)(6) year old male patient expired.The surgeon used a vessel sealer extend (vse) to ligate an unspecified vessel and nicked the vessel resulting in unspecified blood loss.The case was converted to open, an unspecified amount of blood was transfused, and the surgical staff performed cardiopulmonary resuscitation (cpr) with defibrillator paddles but were unsuccessful.The patient expired.The cause of death reported by hospital administration post their internal investigation was ¿cardiac arrest due to blood loss.¿ hospital administration attributed the cause of the intra-operative complications resulting in patient death to ¿surgical error; surgeon related.¿ the site reported that ¿there was clearly a surgeon mistake¿ and the hospital has deemed the event to ¿surgeon error¿ and that ¿no robot issues caused this event.¿ additional details, including additional patient demographics and comorbidities were requested but were not provided and the surgeon is not available for follow-up as he is out on administrative leave.

• 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: 13256625
• MDR Text Key: 283808949
• Report Number: 2955842-2022-10049
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)M90210504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: M90210504 0041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White