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

Model Number 380652-41

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

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 11/01/2021

Event Type  Death  

Event Description

It was reported that during a da vinci-assisted distal pancreatectomy, the patient began to experience cardiac arrest. In an attempt to revive the patient, the patient was undocked from the da vinci surgical system to perform cardiopulmonary resuscitation (cpr), but the patient ultimately expired. There was no allegation of a malfunction or product deficiency. The robotics¿ coordinator, who initially reported the event to an intuitive surgical, inc. (isi) representative, indicated that the event was ¿not robotic related. ¿ isi contacted the operating surgeon and obtained the following additional information regarding the event: the surgeon confirmed that the entire event took place within the operating room (or) and that the patient¿s cause of death was a heart attack. The surgeon reported that the cause of the patient coding was arrhythmia and myocardial ischemia from an occluded coronary stent. The surgeon reported that cpr was the only medical intervention administered. The surgeon reported that he does not think that a da vinci system, instrument, or accessory caused or contributed to this event. The surgeon reported that an autopsy has been performed, but that a copy is not available for isi¿s review at this time. Finally, the surgeon noted that their site is going to perform simulation training in the or for rapid undocking.

Manufacturer Narrative

Based on the information currently available, the surgeon believes the cause of the reported cardiac arrest and subsequent patient expiration is arrhythmia and myocardial ischemia from an occluded coronary stent. However, it is unknown if the da vinci surgical system was a contributing factor to the complication. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. If additional information is received, a follow-up mdr will be submitted. A review of the site's complaint history does not reveal any additional complaints involving this event. No image or video clip for the reported event was submitted for review. A review of the site's system logs for the reported procedure date was completed. The 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 event. Additionally, all instruments used during this procedure were used in subsequent procedures except for the following: the tip-up fenestrated grasper which expended its last use during this procedure, the permanent cautery hook (part number: 470183-14 / lot number: n11210308-0076 / 9 uses remaining), and the large clip applier (part number: 470230-12 / lot number: n10180723-0064 / 88 uses remaining). A vessel sealer extend was used during this procedure. This instrument is a single-use instrument and therefore was not reused in subsequent procedures. None of the instruments used during this procedure have complaints reported against them. This complaint is being reported due to the following conclusion: during a da vinci-assisted distal pancreatectomy, the patient experienced cardiac arrest and then ultimately expired after the robot was undocked and attempts were unsuccessfully made to resuscitate the patient. Although the surgeon indicated that the cause of the patient coding was arrhythmia and myocardial ischemia from an occluded coronary stent, it is unknown if the da vinci surgical system was a contributing factor. There is no allegation that a malfunction of the da vinci surgical system occurred. Blank mdr fields: follow-up was attempted, but the missing 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.

• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13035565
• MDR Text Key: 282481199
• Report Number: 2955842-2021-11773
• Device Sequence Number: 1
• Product Code: NAY
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 380652-41
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• 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 Treatment Data

Date Received: 12/18/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES.