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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 381121-27
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the facility to further troubleshoot the issue. The fse replaced the endoscope controller to correct the reported problem. The system was verified and ready for use. Intuitive surgical, inc. (isi) received the endoscope controller involved with this complaint and completed the evaluation. Failure analysis was able to confirm the original complaint. The unit was placed and driven on an in-house system and failed with error 319 at system start up. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. Log review could not be performed since the endoscope controller unit does not get captured by the logs. No images or videos were shared for the event. System log review done by tse show error 95: a board has reported a temperature that is beyond the operating range occurred after the start of the procedure. Error 319 node was not present at start up occurred after mid-procedure restart. Based on the information provided, this event is being reported due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted. Although no patient harm occurred, if the reported malfunctioned were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, the system had an overheating error. The intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and found error 95. A board has reported a temperature that is beyond the operating range and error 319. Node was not present at start up. The tse exhausted troubleshooting steps with the customer and was unable to resolve the issue. The customer elected to convert the procedure to a laparoscopic procedure with no reported injury. Isi contacted the customer and obtained the following information: from what she can remember, the issue happened at the beginning of the procedure. The surgical team contacted the isi tse, but the issue was not resolved. The surgeon made the decision to convert the procedure to a laparoscopic procedure once all troubleshooting steps were completed. There was no injury to the patient and she is unaware of any reports of any injury to the patient post surgical procedure. She did not have any patient-related information at the time of the call.
 
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Brand NameDAVINCI XI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10955696
MDR Text Key241448358
Report Number2955842-2020-11309
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 health professional,other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381121-27
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2017
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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