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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 380652-37
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4) received the universal motion controller (umc) board for failure analysis investigation, however, the investigation is still in progress. Therefore, the root cause of the customer reported failure has not been determined. A follow-up mdr will be submitted to the fda once the failure analysis investigation has been completed and/or if additional information is received. This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure. Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the customer experienced a non-recoverable error 40067 while the system was in idle. The customer was able to recover from the fault and restarted the system. The customer then called back and stated that the issue returned. The intuitive surgical, inc. (isi) technical support engineer (tse) had the customer with troubleshooting assistance but the issue could not be resolved. The customer decided to convert and complete the procedure as an open traditional surgical procedure. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the customer site and confirmed the customer reported failure via error logs. To resolve the issue, the fse replaced the universal motion controller (umc) board.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the unit involved with this complaint and completed the device evaluation. Failure analysis was not able to reproduce the customer reported failure. However, the error was confirmed to have occurred via system logs. The board was installed in a test system and came up with no errors and all the gantry motors were driven through their full range of motion with no issues. The system ran 10 power cycles with this board with no errors and remained in the system for over an hour with no issues. A review of the error logs for the remote system found that the 40067 error was logged shortly after the system logged error code 31226 which is an aurora communication link error, this indicates that the error could have been caused by a bad fiber cable or bad connection. No trouble found with the board.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT SIDE CART, 4-ARM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
MDR Report Key7600708
MDR Text Key111341762
Report Number2955842-2018-10286
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-37
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/14/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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