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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 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 fse confirmed the occurrence of error 25588 on the system and replaced the remote arm controller (rac) to resolve the issue. While on-site, the fse cleaned the vision side cart (vsc) filters due to being dirty and replaced a broken release tab. The system was tested and verified as ready for use. The release tab (pn: 315111-02) involved with this complaint is a field scrap item and will not be returning for further investigation. Isi received the other part involved with this complaint and completed the device evaluation. Failure analysis investigation replicated the reported failure with the rac. The unit was installed into the test system and it failed with error 25588 after performing 10 power cycles. Upon investigation, it was determined that rac drive module (rdm) 1 board was the cause of the issue. 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 reported 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. The patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Implant date is not applicable because the product is not implantable. Information for the blank fields is not available. Recall is not applicable.
 
Event Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, error 25588 occurred. The customer contacted intuitive surgical, inc. (isi) technical support to report the issue. The customer stated that they power cycled the system but the error persisted. The technical support engineer (tse) recommended resetting the right master tool manipulator (mtm) position to normal and hard power cycling the system but according to the customer, the error persisted post following the tse's instructions. The tse then advised the customer to disable the right mtm and recover the fault after performing a hard power cycle and the customer confirmed that the system was ready for use with 1 mtm disabled post implementing the tse's advise. The tse explained to the customer that this error might have been caused by the right mtm and the customer reportedly elected to continue performing the procedure using 1 mtm. All troubleshooting was completed with technical support prior to the customer electing to continue the procedure using 1 mtm. The procedure was completed using 1 mtm with no reported injury. Isi followed up with the initial reporter and obtained the following additional information: 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 Key11074852
MDR Text Key223784120
Report Number2955842-2020-11404
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
1 Patient was 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 Number380677-17
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 Manufactured08/20/2019
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

Patient Treatment Data
Date Received: 12/28/2020 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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