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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DA VINCI DA VINCI SURGICAL SYSTEM Back to Search Results
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. ".
 
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Brand NameDA VINCI
Type of DeviceDA 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 Key8637856
MDR Text Key146216538
Report Number2955842-2019-10375
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
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 Received05/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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 Treatment Data
Date Received: 05/23/2019 Patient Sequence Number: 1
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