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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 Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted benign tongue base resection surgical procedure, it was not possible to control instruments from surgeon side console (ssc): the surgery was completed with ssc. The site called technical support after surgery to troubleshooting. The tse asked them to install one instrument and endoscope. The tse asked to use the ¿take all¿ function from ssc 1. The instrument list was present but could not be controlled from ssc 1. The user accidentally disconnected the blue fiber cable from ssc 1. The tse asked to power cycle the ssc and reseat the blue fiber cable that was disconnected. The user was able to drive the instrument from ssc 1 after using the ¿take all¿ feature. The caller tested ssc 2 and was able to drive instruments after using ¿give all¿ feature from ssc 1. The tse reviewed the system logs and did not find any issues. The procedure was completed with no reported injury using the second ssc. 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.
 
Manufacturer Narrative
The reported issue was addressed with phone support. The field service engineer (fse) followed up with the customer and found the issue was caused by the unexpected unplugging of the blue fiber cable. After the blue fiber cable was reseated and the system was restarted, everything worked well. No site visit was conducted. The system was working properly and no additional action was required. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient¿s inability to tolerate a procedure change. 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. Blank mdr fields: follow-up was attempted, but 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. Pma/510(k) number and adverse event are not applicable.
 
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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 Key13795259
MDR Text Key287337677
Report Number2955842-2022-10639
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110744
UDI-Public(01)00886874110744
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2016
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

Patient Treatment Data
Date Received: 03/17/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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