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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI VISION SIDE SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI XI VISION SIDE SYSTEM Back to Search Results
Model Number 381121-30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 11/19/2021
Event Type  Injury  
Event Description
It was reported that during a da vinci-assisted gastric bypass procedure a small fire started in the operating room (or) causing the patient to be burned. On (b)(6) 2021, intuitive surgical inc. (isi) contacted the clinical territory associate (cta) who reported this event and additional information was obtained about the complaint: the cta was present during this procedure and event. The site had been using a vessel sealer extend (vse) during the procedure. The vse was reinstalled on the system and a ¿blade exposed¿ error appeared. A scrub tech in the or then unplugged this vse, removed it from the system, and replaced it with a new vse instrument. The scrub tech placed a sticker to indicate the used vse instrument was to be returned to isi for a failure analysis investigation and then cut the instrument cord for an unknown reason. This cut vse instrument was left in the or near the patient bed, unplugged. The procedure was continued without any further issues until the end of the case. At the end of the procedure, the surgeon was suturing the patient port sites when the surgical staff smelled smoke and noticed a fire starting on the patient bed where the laparoscopic camera cable, insufflation tube, and the cut vse cable were all together. At this point, the cut vse cable had been unplugged for at least three hours as reported by the present cta. A nurse in the room then poured water to put out the fire. The patient sustained a burn on the ribs and armpit area which was treated with an ointment at the moment. It is unknown if any other treatment was provided for this event. According to the cta, the site initially believed this cut vse cable may have caused or contributed to this fire and patient burn. The site was also investigating if all of the cables being together may have caused or contributed to this event. On (b)(6) 2021, isi received the following follow-up information regarding the event: the customer site brought in a third party investigation company to look into why the fire started. The site is reportedly not communicating the investigation to any isi representatives. However, the site and investigators are no longer looking into isi and da vinci products as the potential cause of the fire.
 
Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined. The site is currently using a third party investigation company to look into the cause of this event. However, the customer site is unwilling to share the results of the investigation with isi. A follow-up mdr will be submitted if additional information is obtained. An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The reported complaint was not confirmed based on the field evaluation. The fse downloaded and reviewed the erbe and e-100 logs: no errors were found. The fse performed electrical safety tests and test drove the system while using energy: the system performed normally and as expected. The customer asked the fse to use the vse that was used during the procedure. The fse installed the vse onto arm1 and received a message stating "instrument not valid" and prevented the use of the vse. The fse noticed that the white connector cable on the vse was burned. The system logs were downloaded and error 282 was noticed in the logs while the fse was present and noticed the same error occurred on the day of this reported event. The system was tested and verified as ready for use. The da vinci system logs were reviewed by a failure analysis engineer and the following information was provided: "all of the errors in the logs for that procedure are class 0 (system service advisory (no fault reaction)) and class 8 (engineering event informational (no fault reaction)). Note that the error 1155 occurred 2 hours before the end of the procedure so it would not be related to burning that occurred at the end of the procedure. " an additional failure analysis engineer viewed this event and provided the following information on the potential for energy to be maintained in the instruments and cords: the vessel sealer extend instruments and cables do not hold energy after being unplugged. " there are no capacitors or means of energy storage within the vse (or other bipolar instruments) or integrated cord. The iesu is the power source, so after being unplugged, the vse and it¿s cord will not hold any residual energy. Additionally, when the instrument is not being activated by the foot pedals, there is no energy delivered through the conductor path. " there would be a potential for arcing if the vse with the cut bipolar cord was plugged into the esu and the energy were to be commanded to activate. However, the vse instrument would need to have been installed on the patient side cart arm or else the instrument could not be energized via system commands. The instrument logs for this procedure confirm that two vse instruments were used. Vse part number: 480422-01 / lot number: l91210902-0344 was used for 20 minutes while vse part number: 480422-01 / lot number: l90210822-0402 was used for 19 minutes. The vse that had an exposed blade error and had the cord cut is expected to be returned to isi for failure analysis (fa) evaluation. This event is being reported due to the following conclusion: at the end of a da vinci-assisted surgical procedure, the patient reportedly sustained a burn of unknown severity to the rib and armpit areas. The patient received ointment for this burn; however, it is unknown if any other treatment or intervention was performed for this event. Additionally, the cause of the fire in the or is unknown. Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.
 
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Brand NameDAVINCI XI
Type of DeviceVISION SIDE SYSTEM
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 Key13026443
MDR Text Key288100897
Report Number2955842-2021-11764
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
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number381121-30
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2018
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: 12/17/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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