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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 380652-49
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/30/2021
Event Type  Injury  
Event Description
An intuitive surgical, inc. (isi) representative reported that approximately 10 minutes after starting a da vinci-assisted cholecystectomy procedure, a recoverable ¿left video was lost¿ fault occurred with an endoscope that intermittently had the same issue a week prior. Despite previous occurrence of the same reported error, the endoscope passed all self-tests and functioned as expected when installed for the reported procedure. The reported error did not result in a loss of vision but a conversion from a three-dimensional (3d) to a two-dimensional (2d) depiction of the surgical field. Despite the error message/conversion to 2d, the vision was reportedly sufficient, so the surgeon continued with dissection of fatty tissue to identify the cystic duct artery (assisted by firefly) while the isi representative called in the issue to isi technical support. An isi technical support engineer (tse) reviewed the live system logs and noted that the error pointed towards the endoscope. As the isi tse recommended that the site replace the endoscope, the isi representative reporting the issue stated that the patient started to bleed. As a result of the bleed, the surgeon began to apply pressure to it. Shortly after the bleed began, and while the isi representative was still on the phone with isi technical support, the endoscope vision on all screens turned to color bars. To resolve the loss of vision, the isi representative terminated the call with isi technical support to retrieve an endoscope from a nearby room, which was reported to have taken less than 60 seconds. After regaining vision with the new endoscope, the surgeon cauterized the bleeding tissue with a monopolar curved scissors (mcs) instrument to resolve it. The isi representative did not know how much blood was lost or exactly what tissue was bleeding during the event, but the surgeon indicated that the bleed was minor. Firefly: the fluorescence-capable da vinci fluorescence imaging vision system is an endoscopic imaging system for high definition (hd) visible light and near-infrared fluorescence imaging. Firefly is an optional visual feature and is not required to complete a surgical procedure.
 
Manufacturer Narrative
Isi received the endoscope involved with this complaint and completed the device evaluation. Failure analysis confirmed but did not replicate the reported problem. During testing, the endoscope had good vision in both eyes and no errors were generated. However, errors related to the reported event were discovered in the endoscope logs. An isi field service engineer (fse) contacted the isi representative that reported the issue and confirmed that the issue was resolved with a spare endoscope. No site visit was conducted by the isi fse as the system was working properly and no additional action was required. A review of the system/instrument logs for the procedure was performed and the following was observed: multiple instances of error 45311 were noted in the logs indicating a loss of left video for the reported endoscope (part number: 470057-05 - serial number: (b)(4)). Following the 45311 errors, error 45310 and 45312 occurred indicating a total loss of endoscope video and frozen video. All of these errors occur approximately eleven minutes after the system entered following mode, which corresponds with the reported sequence of events. Additionally, the mcs instrument used during this procedure has been reused in subsequent procedures with no reported issues. This complaint is being reported because the patient began to bleed during dissection of fatty tissue to identify the cystic duct artery. The reported bleed required the application of pressure and cauterization. Although the surgeon indicated that the bleed was minorl, the cause and source of the bleed are unknown.
 
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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 Key13065813
MDR Text Key287613805
Report Number2955842-2021-11797
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 Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-49
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2021
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
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: 12/22/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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