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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
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.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT 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 Key13035565
MDR Text Key282481199
Report Number2955842-2021-11773
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
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 Received12/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-41
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/18/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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