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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 380677-04
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
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 was able to isolate the issue by having the customer power up in standalone. Upon arrival, the fse swapped dvi cables at the pmsc with no vision staying on right eye. The monitor was checked by trying a new monitor which showed an image. The fse replaced and aligned a new high resolution stereo viewer (hrsv) monitor to resolve the issue. The hrsv monitor has been returned for evaluation; however, the device evaluation has not been completed. A follow-up mdr will be submitted post engineering evaluation or if additional information is received. A review of the site's complaint history does not reveal any related complaints involving this product or this event. No image or procedure video was provided for review. This complaint is being reported based on the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that there was no image in an eye of the ssc. 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 conversion/abortion. 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.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, one of the eyes was not working in the surgeon side console (ssc). The customer contacted technical support and noted that the vision side cart (vsc) had vision in both eyes even though the ssc did not. The technical support engineer (tse) then asked if they had tried swapping scopes, power cycling, hard cycling, and verifying blue fibers. The customer stated that or staff had tried all that with the clinical sales representative (csr) who was on site and did not wish to do so again as surgeon was working through the issue. System logs were not available as the system was not connected to onsite. The site was continuing the procedure using one eye in the ssc. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
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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 Key13091396
MDR Text Key287017628
Report Number2955842-2021-11820
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-04
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/28/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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