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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 380652-36
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)
Event Date 11/04/2021
Event Type  Death  
Manufacturer Narrative
Based on the current information provided, the root cause of the injury and patient expiring is unknown. There was no report or allegation from the customer of a deficiency of the da vinci system, instrumentation or accessories associated with the reported incident. Therefore, there are no products expected for return to intuitive surgical, inc. (isi) for failure analysis evaluation. A follow up mdr will be submitted if additional information is received. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. Verification of the event details via system logs and log reviews cannot be performed at this time because the event date of the procedure is unknown. No image or video clip for the reported event was submitted for review. A medical review was performed by an isi medical safety officer and the following information was provided. Based upon the description in the description of event, there is insufficient information to make a determination if the da vinci system, instrumentation, and/or accessories caused or contributed to the iliac artery injury resulting in a hemorrhage and death. It is unknown what instruments were being used at the time of injury. It is unknown as to what instrument directly injured the iliac artery. The degree of the injury to the iliac artery is unknown. It is unknown what surgical task the surgeon was performing at the time of the injury. The surgeon¿s level of experience is unknown. It is unknown if the surgeon is qualified to perform an arterial repair. Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted malignant hysterectomy procedure, there was an injury to the iliac artery which resulted in bleeding. The surgeon elected to convert the case to open; however, the patient subsequently expired. Although there is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, the cause of the intra-operative complication is unknown.
 
Event Description
It was reported that during a da vinci-assisted malignant hysterectomy procedure, an injury to the iliac artery occurred and there was a hemorrhage. The surgeon initially tried to control the bleeding robotically but ended up converting the procedure to open. The patient expired. Intuitive surgical, inc. (isi) made multiple follow-up attempts to contact the surgeon, robotic coordinator, risk management, surgical service director, and executive director of surgical services to obtain additional information. However, no further details have been received as of the date of this report.
 
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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
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12995439
MDR Text Key282179671
Report Number2955842-2021-11739
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-36
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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