MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Heart Failure (2206); Blood Loss (2597)

Event Date 03/27/2015

Event Type  Death  

Manufacturer Narrative

Based on the information provided, isi has not determined the root causes for the alleged post-operative complications experienced by the patient and her subsequent demise.The following information is unknown: what specific operative damages the patient sustained, and what the root causes were for the alleged operative damages, cardiopulmonary failure, post-operative bleeding, and death.In addition, the name of the facility where the da vinci-assisted surgical procedure was performed is unknown.Likewise, the name of the surgeon who performed the surgical procedure is unknown.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 underwent a da vinci-assisted surgical procedure, sustained unspecified damages, experienced post-operative complications, and subsequently expired.However, at this time, the root causes of the alleged operative complications are unknown.

Event Description

As part of a legal dispute, intuitive surgical, inc.(isi) received information regarding a patient who underwent a da vinci-assisted hysterectomy procedure on (b)(6) 2015 and allegedly sustained unspecified damages.The plaintiff's attorney claimed that immediately following surgery, the patient developed a cardiopulmonary failure and suffered from bleeding which led to her death.Isi was not provided with the operative report or any of the patient's medical records.

• Brand Name: DA VINCI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 6547776
• MDR Text Key: 74529440
• Report Number: 2955842-2017-00276
• 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
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention