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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 380677-14
Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2020
Event Type  malfunction  
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse replaced the mtm. The gimbal would spin very fast during homing. The system was tested and verified as ready for use. The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon's side console. One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr). Isi received the mtm involved with this complaint and completed the device evaluation. Failure analysis investigation reproduced the reported failure. The failure was replicated during calibration via (b)(6). A review of the site's complaint history does not show any additional complaints related to this event. No image or video clip for the reported event was submitted to isi for review. Based on the information provided at this time, this complaint 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. 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 sigmoid colectomy surgical procedure, error 23025 occurred. The technical support engineer (tse) advised the customer to restart the system with an emergency power off (epo), but this had no effect. The tse reviewed the logs and confirmed the error 23025 pointing to the master tool manipulator (mtm) left axis 7. The customer requested to use another surgeon side console (ssc) from a different system, and the tse confirmed this was possible. The tse had the customer take out the instruments, shutdown the system, and exchange the ssc. After this, the system started up with no problem. The procedure was converted to another da vinci system with no reported injury. Intuitive surgical, inc. (isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
 
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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 Key11058243
MDR Text Key242900604
Report Number2955842-2020-11393
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-14
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
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

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