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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 380677-23
Device Problem Visual Prompts will not Clear (2281)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted radical hysterectomy surgical procedure, a repeated non-recoverable fault, an error 23 was displayed. The caller stated that after they hard cycled the system a recoverable and then another non-recoverable error was received. Intuitive surgical, inc. (isi) technical support engineer (tse) confirmed that the customer had error 23. The isi tse advised the caller that the error 23 was pointing to a fiber-related issue. The caller stated that they powered down and then reseated all the fiber cables and were in the process of powering back on. The system powered back up without error and isi tse heard ¿da vinci is ready¿. The site continued with the procedure. The customer called back and informed the isi tse that the error had returned. The caller removed the surgeon side console (ssc) and swap to a backup ssc. Onsite logs showed error 307 on ssc1 master tool manipulators (mtm). The procedure was completed with no reported injury. Isi followed up with the robotics coordinator and obtained the following additional information: they used another ssc to complete the case. The customer was not aware of any relevant tests performed.
 
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The reported complaint was confirmed based on the field evaluation. Isi fse switched the right master tool manipulators (mtm) to the left and installed a new mtm on the right to resolve errors 40421 and 23. The system was tested and verified as ready for use. Isi received the mtm involved with this complaint and completed the device evaluation. Failure analysis investigation reproduced the reported "error 23" via (b)(4). The embedded sterilizer in master base (esmb) printed circuit assembly (pca) and main wire harness will be replaced to resolve the issue. A review of the site's complaint history does not reveal any related complaints involving 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. Investigation confirmed the reported errors. 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 and may lead to an injury due to the patient¿s inability to tolerate a conversion. 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. Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.
 
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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 Key13081685
MDR Text Key284806003
Report Number2955842-2021-11800
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110744
UDI-Public(01)00886874110744
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-23
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2021
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: 12/23/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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