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

Model Number 380652-50

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

Patient Problems Failure to Anastomose (1028); Fistula (1862); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2021

Event Type  Injury  

Event Description

Intuitive surgical inc. (isi) became aware of a balkan medical journal article titled, ¿early experience with salvage robotic-assisted radical prostatectomy in proton beam radiotherapy failures¿ (bozkurt, y. , atar, m. , et al. , 2021). Within the journal article, post-operative complications involving da vinci-assisted surgical procedures were noted: "anastomotic leaks were observed in 5 patients (50%). Even though they were managed with prolonged catheterization, a bladder neck contracture eventually occurred in most patients. Bladder neck contractures developed in 6 patients and were managed with direct-vision internal urethrotomy and/or transurethral resection of the bladder neck in 5 patients. Vesicopubic fistula with breakdown of the vesicourethral anastomosis plus bladder neck contracture were observed in 1 patient, and managed with robotic salvage radical cystectomy-ileal conduit plus urethrectomy at the sixth month. " on 13-dec-2021, intuitive surgical inc. (isi) contacted the author correspondent and the following information was obtained: the reported adverse events are related to the damage received from proton beam radiation in the patient population. The author correspondent reported that these adverse events are not related to the da vinci robot or any instruments.

Manufacturer Narrative

According to the author correspondent, the reported adverse events are related to the damage received from proton beam radiation in the patient population. Additionally, the author correspondent indicated that the complications are not related to the da vinci surgical system. There is no allegation that a malfunction of an da vinci system, instrument, or accessory occurred. Therefore, no product is expected to be returned. A follow-up mdr will be submitted if additional information is obtained. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. The following investigations could not be performed due to insufficient information provided (i. E. Event date, system serial #, surgeon name): event verification, system/instrument log review. No image or procedure video were provided for review. This complaint is being reported due to the following conclusion: within the balkan medical journal article titled, ¿early experience with salvage robotic-assisted radical prostatectomy in proton beam radiotherapy failures," it is noted that multiple patients reportedly experienced post-operative anastomotic leaks and/or bladder neck contractures. Some patients required prolonged catheterization, a urethrotomy and/or transurethral resections of the bladder neck to resolve the complications. Although the author correspondent indicated that the complications are unrelated to the da vinci surgical system and were related to the damage received from proton beam radiation, the root cause(s) of the reported post-operative complications are unknown. There is no allegation that a malfunction of an 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: 13026129
• MDR Text Key: 284133304
• Report Number: 2955842-2021-11762
• 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

• 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 Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 380652-50
• 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: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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 Treatment Data

Date Received: 12/17/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES