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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 380677-06
Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The reported complaint was confirmed based on the field evaluation. The fse confirmed that the surgeon back plane (sbp) board failed causing a recognition failure in the head sensor section of the ssc. To resolve the issue, the fse replaced the sbp board and remote arm controller (rac). The system was tested and verified as ready for use. Isi received the parts involved with this complaint and completed the device evaluation. Failure analysis investigation replicated/confirmed the reported failure. The sbp was installed onto a test system and tested with the rac which it came back with. Ten power cycles were run and the parts were left sitting idle for one hour. After an hour, error 1150 did occur. Error 1150 was found to be caused by the sbp as opposed to the rac. No trouble was found with the rac. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was submitted for review. Based on the information provided at this time, this complaint is being classified as a non-reportable event because: system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, error 1150 occurred and the customer tried to power cycle but error 500 occurred. The customer contacted intuitive surgical, inc. (isi) technical support to report the issue. The technical support engineer (tse) advised the customer to hard power cycle the surgeon side console (ssc); however, the issue persisted post following the tse's instruction. The customer reportedly decided to proceed laparoscopically with the procedure. Isi followed up with the initial reporter and obtained the following additional information: the system functionality was checked upon powering on the system and the system initially powered on without errors. Ports had been placed at the time of the issue's occurrence. All troubleshooting was completed with technical support; however, the issue persisted so the customer decided to convert to laparoscopic surgery. The procedure was completed laparoscopically and no injury occurred to the patient.
 
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Brand NameDAVINCI XI
Type of DeviceSURGEON SIDE CONSOLE, SMART PEDALS
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 Key11074893
MDR Text Key241730489
Report Number2955842-2020-11405
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 foreign,other
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-06
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2016
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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