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 Problem Fistula (1862)

Event Date 10/30/2021

Event Type  Injury  

Event Description

On 18-jan-2022, intuitive surgical, inc.(isi) became aware of a journal of robotic surgery article titled, ¿potential advantages of robotic total gastrectomy for gastric cancer: a retrospective comparative cohort study¿ (kumamoto, t., ishida, y., et al., 2021).Within the journal article, post-operative complications involving a da vinci surgical procedure were noted: "grade a fistulas were observed in 15 patients (57.7%) in the rtg (robotic total gastrectomy) group and 18 patients (62.1%) in the ltg (laparoscopic total gastrectomy) group (p = 0.603).Among patients with bmi = 25 kg/m2, grade a fistulas were observed in 2 patients (33.3%) in the rtg group and 6 (75%) patients in the ltg group (p = 0.277).Among patients with bmi < 25 kg/m2, grade a fistulas were observed in 13 patients (65%) in the rtg group and 12 (57.1%) in the ltg group (p = 0.751)." isi has reached out to the author to gather additional information regarding the reported events; however, no information can be obtained at this time due to the covid-19 pandemic.

Manufacturer Narrative

Based on the information provided, the root cause of the reported post-operative complications cannot be determined.There is no allegation within the journal article that a malfunction of a da vinci system, instrument, or accessory occurred.A site complaint history review was unable to be conducted at this time due to lack of instrument detail and lack of specific event/procedure details.No image or video clip for the reported event was submitted for review.System and instrument log reviews could not be performed due to a lack of system, procedure, and instrument details.This complaint is being reported due to the following conclusion: within the clinical article titled, ¿potential advantages of robotic total gastrectomy for gastric cancer: a retrospective comparative cohort study," it is noted that 15 patients experienced grade a fistulas in the rtg group.The cause of the post-operative complications are unknown.It is also unknown was medical intervention, if any, was rendered due to the post-operative complications.There is no allegation within the journal article that a malfunction of a da vinci system, instrument, or accessory occurred.

• 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: 13518864
• MDR Text Key: 289667973
• Report Number: 2955842-2022-10234
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 01/18/2022
• 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