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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pseudoaneurysm (2605)
Event Date 03/02/2022
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. Therefore, no product is expected to be returned. A follow-up mdr will be submitted if additional information is obtained. A system and instrument log review cannot be performed due to insufficient information provided. The event date and procedure information cannot be verified. In addition, the system serial # and surgeon name are unknown. This complaint is being reported due to the following conclusion: during a da vinci-assisted pulmonary lobectomy procedure, the patient experienced a pseudoaneurysm. The cause of the a pseudoaneurysm is unknown. Furthermore, the intervention administered (if any) to specifically treat the pseudoaneurysm is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.
 
Event Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, the patient was found to have a pseudoaneurysm. The physician indicated that this patient was scheduled for a wedge resection, so this event was not very impactful. Intuitive surgical, inc. (isi) performed multiple follow-up attempts to obtain additional information. However, as of the date of this report, no further details have been received.
 
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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 Key14245289
MDR Text Key294648437
Report Number2955842-2022-11293
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,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652
Device Catalogue Number380652
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
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
Removal/Correction NumberN/A

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