• 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 SI 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 SI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380614-08
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Rash (2033)
Event Date 10/04/2021
Event Type  Injury  
Event Description
Intuitive surgical, inc. (isi) became aware of a pediatric surgery international article titled, ¿robotic soave pull-through procedure for hirschsprung¿s disease in children under 12-months: long-term outcomes¿ (delgado-miguel, c. And camps, j. I. , 2021). Within the journal article, post-operative complications involving da vinci surgical procedures were noted: "partial anastomosis dehiscence was observed in one patient, requiring reoperation on the 4th postoperative day. " "constipation occurred in two patients: in one case secondary to sphincter hypertonia which was treated with botulinum toxin injection, and in the second case due to stenosis of the anastomosis in the patient who suffered a dehiscence, which required exploration under anesthesia and dilatation with hegar dilators. In both cases, constipation was finally resolved, with 1¿2 stools per day 2 years after the robotic pull-through. " "one patient experienced mild postoperative enterocolitis 6 months after surgery, which required intravenous antibiotic treatment, with no other subsequent complications. " "perineal rash was observed in three patients, which progressively improved during follow-up with increasing solid diet consistency. " isi made multiple follow-up attempts to obtain additional information from the author. However, no further details have been received as of the date of this report. ".
 
Manufacturer Narrative
Based on the current information provided, the causes of the patients' post-operative complications are unknown. Isi has attempted to contact the author to gather additional information regarding the patients/incidents. However, as of the date of this report, no new information has been obtained. If additional information is received, a follow-up mdr will be submitted. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the system and instrument logs was not possible due to lack of system and instrument detail, event/procedure date, and confirmation of site location. No image or video clip for the reported event was submitted for review. This complaint is being reported due to the following: within the pediatric surgery international article titled, ¿robotic soave pull-through procedure for hirschsprung¿s disease in children under 12-months: long-term outcomes,¿ a number of operative complications involving patients who underwent da vinci-assisted surgical procedures were noted. As a result of these complications, the patients required additional surgical or medical intervention. At this time, the causes of the operative complications are unknown. There is no allegation that a malfunction of a da vinci surgical system occurred. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAVINCI SI
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 Key13025775
MDR Text Key288104755
Report Number2955842-2021-11761
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Literature
Reporter Occupation
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 Number380614-08
Device Catalogue Number380614
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 Manufactured10/21/2011
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.
-
-