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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS

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INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS Back to Search Results
Model Number 380677-13
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the unit involved with this complaint, however the device evaluation is still in progress and has not been completed. A follow-up mdr will be submitted once the device evaluation has been completed or if additional information is received. The complaint is being reported du 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 the reported malfunction were to recur, it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the right eye in the surgeon side console (ssc) was black. The customer changed scopes and restarted the system but the problem persisted. The intuitive surgical, inc. (isi) technical support engineer (tse) instructed the customer to check the console monitor and it was black. The tse instructed the customer to cycle the breaker on the surgeon console but the problem persisted. The surgeon made the decision to convert and complete the procedure as a traditional open surgical procedure. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the facility and found the left eye in ssc was not displaying an image versus the right eye. To resolve the issue, the fse replaced the high resolution stereo viewer (hrsv). The hrsv provides the video image for the ssc.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the high resolution stereo viewer (hrsv) involved with this complaint and completed the device evaluation. Failure analysis confirmed the customer reported failure. There was no image and the main board was found to be defective. The printed circuit assembly (pca) main board will be replaced.
 
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Brand NameDAVINCI XI
Type of DeviceSURGEON SIDE CONSOLE, SMART PEDALS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
MDR Report Key7386259
MDR Text Key104158678
Report Number2955842-2018-10108
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 health professional
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-13
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/14/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/30/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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