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

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

Patient Problems Pain (1994); Urinary Tract Infection (2120); Injury (2348)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, isi has not determined the root cause for the alleged operative complications experienced by the patient.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.If additional information is received, a follow-up mdr will be submitted to the fda.No previous complaint was reported relating to this event.This complaint is being reported due to the following conclusion: the plaintiff¿s attorney claims that the patient sustained a severed ureter while undergoing a da vinci-assisted surgical procedure and had to visit a hospital frequently after developing post-operative symptoms.However, at this time, the causes of the patient¿s alleged operative complications are unknown.

Event Description

As part of a legal dispute, intuitive surgical, inc.(isi) received information regarding a patient who reportedly underwent a da vinci-assisted hysterectomy procedure on (b)(6) 2016.The plaintiffs¿ attorney alleges that during the da vinci-assisted surgical procedure, the patient¿s left ureter was severed.As a result, the plaintiff¿s attorney claims that the patient has suffered chronic urinary tract infections, bladder leakage, pain, and other unspecified problems.In addition, the patient has reportedly been a frequent patient at hospitals since the surgery to attempt to correct her problems.Isi was not provided with the operative report or any of the patient¿s medical records.

Manufacturer Narrative

Corrected data - the initial mdr was submitted on 05/23/2019 with the incorrect (type of report) value of "5-day." the correct value for the initial mdr should be "initial" and "30-day," not "5-day.".

• Brand Name: DA VINCI
• Type of Device: DA VINCI SURGICAL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: izabel nielson ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8637856
• MDR Text Key: 146216538
• Report Number: 2955842-2019-10375
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention