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

Model Number 380652-44

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

Patient Problem Cardiac Arrest (1762)

Event Date 02/10/2021

Event Type  Death  

Manufacturer Narrative

Based on the information provided by the patient's family, the cause of the patient's death is cardiac arrest.If additional information is received, a follow-up mdr will be submitted.Isi has made additional attempts to contact the site and gather patient information.However, no new information has been obtained.A review of the site's complaint history does not show any additional complaints related to this event.A review of the site's system logs for the reported procedure date was conducted.The logs show a sureform60 stapler instrument part number 480460-09; lot l90200713-0039 fired six sureform reloads (5 blue, followed by one white).All firings were completed per the logs.Firings #2, 3, and 6 had one pause for compression, and the others did not have any pauses.There were no incomplete clamps by this stapler instrument.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.No images or procedure videos were shared for the event.An isi medical safety officer conducted a review of the event, and the following additional information was provided: the patient underwent a proctored robotic-assisted sleeve gastrectomy on (b)(6) 2021.There were no reported issues with the procedure as indicated by the proctoring surgeon.The patient was discharged to home.By report, the patient expired in his sleep due to a cardiac arrest.Major adverse cardiac events can be a cause of postoperative mortality after bariatric surgery.Although rare, age > (b)(6) years, male sex, congestive heart failure, chronic pulmonary disease, ischemic heart disease, history of pulmonary emboli, and fluid or electrolyte disorders were independent risk factors for major adverse cardiac events.Based upon the information provided in the description of events, it is likely that the patient suffered a major cardiac event after the sleeve gastrectomy procedure.However, based upon the provided information, it cannot be determined if the da vinci system, instrumentation, and accessories caused or contributed to the patient's death.This complaint is being reported due to the following conclusion: it was reported that two days after a da vinci-assisted sleeve gastrectomy surgical procedure, the patient expired due to a cardiac arrest.Although the proctor surgeon had confirmed that there were no intra-operative complications during the procedure, and he was informed that the patient's death was not related to the da vinci system, the cause of the cardiac arrest, and the patient's subsequent death is unknown.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Information for the blank fields for initial reporter is not available.Initial reporter is blank because it is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that two days after a da vinci-assisted sleeve gastrectomy surgical procedure, the patient expired.There was no allegation that a malfunction of a da vinci system, instrument or accessory occurred.The patient's family stated that the patient had died due to cardiac arrest.On 23-feb-2021, intuitive surgical, inc.(isi) contacted the proctor who was present during the procedure and obtained the following information: the surgeon stated that he had proctored the procedure on (b)(6) 2021.There was no malfunction of any isi instruments or accessories during the procedure.The procedure was completed with no reported issues.The surgeon was informed that the patient had expired on (b)(6) 2021 in his sleep secondary to cardiac arrest and not related to the da vinci system.

• 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: 11478465
• MDR Text Key: 239624678
• Report Number: 2955842-2021-10246
• 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: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/12/2021

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: 380652-44
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• 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