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

Model Number 380652-33

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, the cause of the patient's post-operative complications and subsequent death are unknown.There is no allegation that a da vinci system, instrument, or accessory malfunction occurred during the surgical procedure.A system log review could not performed due to insufficient or unconfirmed product/event information.No image or video of the event were provided.As of 09-nov-2020, a review of the site's complaint history does not reveal any related or duplicate complaints involving this event.Medical review: a review of the event was conducted by an isi medical safety officer, and the following additional information was provided: although the attending surgeon denies any causal relationship between the da vinci system and the patient's death, there was not enough information to provide further assessment of the events that caused or contributed to the patient's death, 47 days after surgery.This complaint is being reported due to the following conclusion: it was reported that after undergoing a da vinci-assisted surgical procedure on an unspecified date, the patient developed postoperative sepsis and ultimately expired.Although the surgeon stated that the death was not related to the da vinci system and could happen regardless of the surgical modality, the cause of the postoperative complication and subsequent death is unknown.Since the date of the surgery could not be confirmed, further evaluation of the system or instruments used in the procedure could not be performed.Follow-up was attempted, but the patient information was either unknown, unavailable, or not provided.Outcomes to adverse event was not provided, only that the date of death was 47 days after the surgical procedure.Date of event was not provided.The expiration date is not applicable.Implant date is blank because the product is not implantable.Information is not available.Device manufacture date: there was insufficient product information available to determine the manufacture date.Recall is not applicable.

Event Description

It was reported that approximately 47 days after a da vinci-assisted surgical procedure performed on an unknown date, the patient developed sepsis due to ileus, and subsequently expired.The surgeon does not believe there was a causal relationship with da vinci.The surgeon speculated that this outcome could happen regardless of the surgical modality (meaning it could also have happened it the procedure had been performed via open surgery or laparoscopically).The surgeon stated that "he will be careful about the selection of patients in the future." intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10947682
• MDR Text Key: 219762656
• Report Number: 2955842-2020-11296
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-33
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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
• Patient Outcome(s): Death