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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI DA VINCI SURGICAL SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI DA VINCI SURGICAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Unspecified Vascular Problem (4441)
Event Date 08/17/2021
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the root cause of the reported post-operative complications cannot be determined or is unknown. There is no allegation of a da vinci product malfunction, so no product is expected for return and failure analysis. If additional information is received, a follow-up mdr will be submitted. System and instrument log reviews could not be performed due to lack of system, procedure, and instrument detail. A site history complaint review could not be confirmed due to lack of product information and procedure dates. No image or procedure video were provided for review. This complaint is reportable due to the following: a clinical journal article cited operative complications from a result of a retrospective cohort study. The article reported a total of 18 conversions, with 7 conversions from the robotic approach. Of these conversions, 3 robotic and 1 laparoscopic approach were reactive. In fourteen of these conversions, 4 for the robotic approach and 10 for the laparoscopic approach, were preemptive. The reasons for conversion were due to pelvic bleeding, pancreatic injury, vascular mesocolic injury, distorted anatomy, previous tumor excision, the presence of an advanced tumor, and to perform splenic flexure. At this time, additional event and procedure details, severity of complications, specific medical intervention required, and root cause of the alleged complications are unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.
 
Event Description
On 25-oct-2021, intuitive surgical, inc. (isi) became aware of a surgical endoscopy article titled, ¿does conversion during minimally invasive rectal surgery for cancer have an impact on short-term and oncologic outcomes? results of a retrospective cohort study¿ (abdalla, s. , lupinacci, r. M. , et al. , 2021). Within the journal article, operative complications involving da vinci surgical procedures were noted: the article reported a total 18 conversions, 7 of these conversions were from the robotic approach. Of these 7 conversions, 3 robotic approaches and 1 laparoscopic approach were reactive. Fourteen of these conversions, 4 for the robotic approach and 10 for the laparoscopic approach, were preemptive. The reasons for reactive conversion were due to two patients experiencing intraoperative pelvic bleeding, one patient experienced a pancreatic injury, and patient experiencing a vascular mesocolic injury requiring extended colonic resection and retro-ileal transmesenteric colorectal anastomosis. Additionally, the reasons for preemptive conversion within both the robotic and laparoscopic groups were due to difficult pelvic dissection, narrow pelvis in seven patients, distorted anatomy secondary to previous radiotherapy in four patients, previous transanal tumor excision in one patient, locally advanced tumor in one patient, and one patient preemptive conversion was required to perform safe splenic flexure mobilization. It was not specified in the article which patients initially underwent the robotic or laparoscopic approach prior to converting to laparotomy. Isi has reached out to the author to obtain additional information but has not yet received a response.
 
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Brand NameDAVINCI
Type of DeviceDA VINCI SURGICAL SYSTEM
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 Key12836881
MDR Text Key285951723
Report Number2955842-2021-11534
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2021
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 NumberN/A

Patient Treatment Data
Date Received: 11/18/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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