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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-33
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Internal Organ Perforation (1987); Sepsis (2067)
Event Date 07/14/2017
Event Type  Death  
Manufacturer Narrative
Based on the current information provided, the cause of the patient¿s operative complications and subsequent death are unknown. If additional information is obtained, a follow-up mdr will be submitted. Based on system logs for the site, there were two sleeve gastrectomy procedures conducted on (b)(6) 2017. A review of the system and instrument logs for both procedures has been performed. There were no observed events in the system logs that would suggest a product issue, and the logged events are in line with normal system functionality. Additionally, all instruments used in the cases were used in subsequent procedures, with the exception of the following: vessel sealer instrument, which is a single use instrument, and one of the fenestrated bipolar forceps which was in its last use. Site reviews have shown that no complaints were filed against any of the instruments. There was not enough information to provide further assessment of the events that occurred during the case. This complaint is being reported due to the following conclusion: the plaintiff¿s attorney claims that the patient sustained a fistula/leak/perforation while undergoing a da vinci-assisted surgical procedure. As a result, the patient developed post-operative symptoms, resulting in life-threatening infection, sepsis, and abscess complications. The patient had a couple of additional surgeries and subsequently passed away as a result of medical conditions and complexities of the infection, sepsis, and abscess.
 
Event Description
As part of a legal dispute, intuitive surgical, inc. (isi) received a complaint that contained the following allegations: the patient underwent a robotic-assisted laparoscopic gastric sleeve procedure on (b)(6) 2017. The surgery included removal of the patient¿s gallbladder. A fistula/perforation/leak occurred, leading to leakage of intestinal contents into the patient¿s abdomen, which resulted in a left threatening infection, sepsis and abscess complications between 14-july and 23-august-2017. The patient underwent a second surgery on (b)(6) 2017 to treat said complications and conditions. Between 24-aug-2017 and 25-jan-2018 the patient developed progressive infection, sepsis and abscess formation due to a fistula/perforation/leak. On (b)(6) 2018, a third surgery was performed as an open laparotomy; however, the patient's condition had become irreversible and she expired on (b)(6) 2018 as a result of medical conditions and complications of the infection, sepsis and abscess. Intuitive surgical, inc. (isi) was not provided with the operative report or any of the patient¿s medical records.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT SIDE CART, 4-ARM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key9919017
MDR Text Key186280082
Report Number2955842-2020-10265
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number380652-33
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/02/2020 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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