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

Device Problem Insufficient Information (3190)

Patient Problems Failure to Anastomose (1028); Death (1802); Multiple Organ Failure (3261)

Event Type  Death  

Manufacturer Narrative

Based on the information provided, intuitive surgical, inc.(isi) has not determined the root cause for the alleged post-operative complications experienced by the patient and the patient¿s subsequent demise.Isi has attempted to contact the article¿s correspondence author.However, as of the date of the report, no additional information has been obtained.The event date, death date, and site name where the surgical procedure was performed are unknown.If additional information is received a follow-up mdr will be submitted to the fda.Based on the current information provided, this complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient developed an anastomotic leak and subsequently expired.However, the root cause of the patient¿s operative complications is unknown.

Event Description

On 08/27/2018, intuitive surgical, inc.(isi) became aware of the journal of the society of laparoendoscopic surgeons clinical article titled ¿robotic-assisted transthoracic esophageal diverticulectomy¿ (balci et al., 2018).It was reported that after undergoing a da vinci-assisted ¿transthoracic esophageal diverticulectomy procedure, a patient experienced post-operative complications and subsequently expired." on an unspecified date, the patient underwent the da vinci-assisted surgical procedure for a diverticulum.The patient also underwent wedge biopsies from the right lung.The operative time was 165 minutes and it was noted that there were no intra-operative complications.On post-operative day #2, liquids were started after no leaks were found.On post-operative day #4, the patient had a fever of 100.4 degrees fahrenheit although there was no evidence of leakage.On post-operative day #5, the patient developed respiratory distress in addition to having ongoing fever.A ct-scan was performed for suspicion of an anastomotic leakage.Pleural effusion was observed in the right lung with free fluid and air in the operative area.The patient was transferred to the icu and antibiotics were started with a presumptive diagnosis of anastomotic leakage and mediastinitis.On post-operative day #10, a covered stent was placed in the patient¿s esophagus.The patient¿s pleural space and the leakage area were irrigated and drained daily with a thoracic tube.Per the article, ¿acute respiratory distress syndrome and decreased daily urine output led to multiorgan dysfunction.¿ the patient¿s condition continued to deteriorate and the patient expired on post-operative day #19.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

• Brand Name: DA VINCI SURGICAL SYSTEM
• 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: tabitha reed ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7910087
• MDR Text Key: 121743368
• Report Number: 2955842-2018-10550
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/26/2018
• 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
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65