• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAVINCI XI
Type of DevicePATIENT 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 Key13026129
MDR Text Key284133304
Report Number2955842-2021-11762
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
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 Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-50
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/17/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
-
-