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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 380652-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Thrombosis/Thrombus (4440)
Event Date 11/17/2021
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the root cause of the complication is unknown. However, the patient experienced portal vein thrombosis which is a known potential complication of a sleeve gastrectomy procedure, resulting in ischemic bowel. The patient required a second procedure to resect the ischemic bowel. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. The surgeon stated that the patient's outcome was unrelated to the intuitive products used. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. The logs were reviewed by an intuitive surgical, inc. (isi) advanced failure analysis engineer (fae) and the following findings were obtained: logs show pn 480460-09, lot l90210930-0033 was installed 7x and fired 7 reloads (1 green followed by 6 blue). All firings were completed per the logs. Firing # 1-3 and # 7 had no pauses, firing # 4-6 had 1 pause for compression. There were no incomplete clamps by this instrument. No image or video clip for the reported event was submitted for review. This complaint is reportable due to the following: after a da vinci-assisted sleeve gastrectomy procedure, the patient was readmitted to the hospital on the 12th post-operative day (pod) for abdominal pain. The patient underwent a reoperation on the 13th pod for ischemic bowel and had 50% of the small bowel resected. The surgeon believes that the cause of the complication was portal vein thrombosis. There is no allegation of a malfunction of a da vinci system, instrument and accessory. The surgeon stated that the primary procedure went well with no issues.
 
Event Description
It was reported that after a da vinci-assisted sleeve gastrectomy procedure which went well, the patient was readmitted to the hospital on the 12th post-operative day (pod) for abdominal pain. The patient underwent a reoperation on the 13th pod for ischemic bowel and 50% of the small bowel was resected. The surgeon believes that the cause of the complication was portal vein thrombosis. Furthermore, the surgeon indicated, "upon review, the patient outcome was determined to be unrelated to use of the intuitive robotic surgical device. " all the single used instruments and reloads have been discarded by the site.
 
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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 Key13081834
MDR Text Key284884250
Report Number2955842-2021-11799
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110720
UDI-Public(01)00886874110720
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-50
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2021
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: 12/23/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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