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

Model Number 380652-23

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

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Hemorrhage/Bleeding (1888)

Event Type  Death  

Manufacturer Narrative

Based on the information provided, the cause of the reported complications cannot be determined.There are no allegations that a malfunctions of any da vinci systems, instruments, or accessories occurred.Therefore, no product is expected to be returned.A follow-up mdr will be submitted if additional information is obtained.A site history complaint review and a review of the system and instrument logs were not performed due to insufficient information being provided (i.E.Event dates, system serial #s, surgeon names).No images or procedure videos were obtained for this reported event.This event is being reported due to the following conclusion: within the european journal of cardio-thoracic surgery article titled, ¿robotic off-pump totally endoscopic coronary artery bypass in the current era: report of 544 patients,¿ operative complications involving da vinci surgical procedures were noted.Furthermore, 76 patients reportedly expired of various reasons after undergoing da vinci-assisted procedures.Comment was not received from the customer on the relationship between the da vinci products used during the procedures and the respective patient deaths.Although there is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, the causes of the patient deaths are unknown.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.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.Insufficient product information was provided in order to obtain the date of manufacture.

Event Description

On 11-oct-2021, intuitive surgical inc.(isi) became aware of a european journal of cardio-thoracic surgery article titled, ¿robotic off-pump totally endoscopic coronary artery bypass in the current era: report of 544 patients¿ (balkhy, h.H., nisivaco, s., et al., 2021).Within the journal article, operative complications involving a da vinci surgical procedure were noted: the mortality was 0.9% (o:e ratio 0.6).The causes of mortality in the 5 patients were pulmonary artery perforation secondary to swan-ganz catheter, severe gastro intestinal (gi) bleeding in liver failure patient, bowel ischemia in patient with chronic severe peripheral vascular disease, malignant arrhythmia in patient with patent grafts and ongoing ischemia, and large stroke secondary to carotid stent thrombosis." additionally, the following was noted, "follow-up was completed in 540 patients (99%) at mean 38 months (longest follow-up 7.5 years).All-cause mortality occurred in 76 patients (14%), and cardiac-related mortality in 13 patients (2.4%).Repeat cardiac surgery occurred in 8 patients (1.5%).Twelve patients suffered from mi (2.2%) [3 (0.6%) in a culprit vessel].Re-intervention (culprit vessel) occurred in 15 patients (2.8%)." isi performed multiple follow-up attempts to obtain additional information.However, as of the date of this report, no further details have been received.

Manufacturer Narrative

Additional information can be found in the following sections: g3, g6, h2, and h10 a medical review was performed by an intuitive surgical, inc.(isi) medical safety officer and the following information was provided: "based upon the information in the description of events, i am unable to determine if the da vinci system, instrumentation, and/or accessories caused or contributed to the patient¿s mortalities beyond the 5 patients noted to have a perforation of the pulmonary artery due to a swan-ganz catheter, one patient note to have severe gastrointestinal bleeding in a liver failure patient (unknown if the liver failure was a pre-existing condition), and one patient with bowel ischemia due to chronic severe peripheral vascular disease.".

Event Description

Refer to h10/h11 for follow-up information.

• 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: 12788138
• MDR Text Key: 280593707
• Report Number: 2955842-2021-11479
• 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,Literature
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-23
• 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: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES