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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 380677-17
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 customer site to further investigate the reported complaint. Fse replaced the master tool manipulator (mtm) due to errors 23008, 23013 and 23025. The system was tested and verified as ready for use. Intuitive surgical, inc. (isi) received the mtm involved with this complaint and completed the device evaluation. Failure analysis investigation confirmed/replicated the reported complaint. The unit failed with error code 23013 during calibration via matlab. The axis 6 motor will be replaced as a fix. 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). Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event. System log review: the intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and noted errors 23008, 23013, and 23025 pointing to the master tool manipulator right (mtmr) axis 6 gimbal. Image/video review: no image or video clip for the reported event was submitted for review. This complaint is reportable due to the following: it was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the customer encountered repeated recoverable errors. Intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and noted errors 23008, 23013, and 23025 pointing to the master tool manipulator right (mtmr) axis 6 gimbal. The customer rebooted the system with no resolution to the issue. The surgeon elected to use another surgeon side console (ssc) to continue with the procedure. Isi followed up with the initial reporter and confirmed that the procedure was completed robotically with no injury to the patient. Although there was no patient injury reported, system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.
 
Event Description
It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the customer encountered repeated recoverable errors. The intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and noted errors 23008, 23013, and 23025 pointing to the master tool manipulator right (mtmr) axis 6 gimbal. The customer rebooted the system, but the issue was not resolved. The surgeon elected to use another surgeon side console (ssc) to continue with the procedure. Isi followed up with the initial reporter and confirmed that the procedure was completed robotically with no injury 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 Key10955672
MDR Text Key248142163
Report Number2955842-2020-11308
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 Other Health Care Professional
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 Number380677-17
Device Catalogue Number380677
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
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 Manufactured05/14/2019
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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