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

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.

• Brand Name: DAVINCI
• Type of Device: DA 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 Key: 12836881
• MDR Text Key: 285951723
• Report Number: 2955842-2021-11534
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/18/2021
• 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 Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES