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

Model Number 380614-05

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the causes of the operative complications cannot be determined or are unknown at this time.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.There was no image or video clip supplied for review related to a specific event.System or instrument log reviews could not be performed due to a lack of system, procedure, and instrument detail.An isi clinical development engineer (cde) conducted a clinical article image review and the following was found: from an isi product perspective, we cannot learn much from these images.There is no evidence in these images or article to suggest that isi products malfunctioned or contributed to patient injuries.This complaint is being reported due to the following conclusion: within the journal article titled, ¿cystectomy and ileal conduit for neurogenic bladder: comparison of the open, laparoscopic and robotic approaches,¿ a number of operative complications involving da vinci-assisted cystectomy and ileal conduit procedures were noted.The causes of the complications are unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred or caused/contributed to the complications.

Event Description

On 11-mar-2022 intuitive surgical, inc.(isi) became aware of "neurourology and urodynamics" journal article titled, ¿cystectomy and ileal conduit for neurogenic bladder: comparison of the open, laparoscopic and robotic approaches¿ (haudebert, camille, et al., 2021).The objective of the study was to compare the outcomes of open, laparoscopic, and robotic cystectomy and ileal conduit for neurogenic lower urinary tract dysfunction (nlutd).Study data was collected and retrospectively reviewed` from patient charts who had undergone cystectomy and ileal conduit for nlutd between january 2004 and november 2020, a total of 69 patients were included in the robotic group.The article sited the indication for surgery was for neurogenic bladder.Within the journal article, operative complications involving da vinci-assisted surgical procedures were noted.Of the 69 patients in the robotic group, 4 patients experienced urinary leakage, 13 patients received perioperative blood transfusion, 5 patients experienced pulmonary complications, 6 patients experienced uretero-ileal anastomotic stricture, 1 patient experienced incisional hernia, 1 patient experienced intra-abdominal infections/pelvic abscesses, and 2 patients experienced urosepsis.Intuitive surgical, inc.(isi has made multiple attempts to the author to obtain additional information without success.No response was received.No additional information is available at this time.

• Brand Name: DAVINCI SI
• 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: 14068649
• MDR Text Key: 293927817
• Report Number: 2955842-2022-10980
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081137
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380614-05
• Device Catalogue Number: 380614
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• 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