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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 380677-12
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted unilateral inguinal hernia surgical procedure, the staff was experiencing a recoverable fault and a left hand control disabled message. Prior to calling intuitive surgical, inc. (isi) technical support, the customer attempted a system restart and changed instruments. The isi technical support engineer (tse) viewed live logs and noted error 23032 on the left master tool manipulator (mtm). The button appeared to be pressed at startup. Tse had caller perform a hard reboot of the system. Tse also had caller exercise opto-switches on the left mtm. System powered back up with the recoverable fault still present. Tse had caller bring in another surgeon console from a robot not being used. The customer connected the surgeon console and system powered on and the "da vinci is ready" was heard. The system was redocked and the surgeon took control of instruments and was continuing with procedure. The procedure was converted to another da vinci system and there was no reported injury to the patient. On 16-mar-2022, isi contacted the original reporter and obtained the following information about the complaint: there was no injury to the patient and no fragments fell into the patient.
 
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. Fse found the opto switch sticking and not responding. After moving the opto switch around, it released and looked to be working. Fse replaced the master tool manipulator (mtm) to correct issue. The system was tested and ready for use. Isi received the mtm involved with this complaint and completed the device evaluation. Failure analysis (fa) was able to reproduce the reported issue (opto switch sticking and not responding) during calibration. The opto button assemblies will be replaced as a fix to the reported problem. A review of the site's complaint history does not reveal any related complaints involving this product or this event. No image or video clip for the reported event was submitted for review. A review of the site's system logs for the reported procedure date was conducted by isi technical support when the customer called for support. Investigations revealed error 23032, however, error 23032 could not be found on system sk1341 logs. This complaint is being classified as a reportable event due to the following conclusion: the customer converted after the start of the procedure due to non-recoverable errors. While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion.
 
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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
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key14109669
MDR Text Key289339689
Report Number2955842-2022-11040
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 Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-12
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2017
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: 04/14/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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