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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 380677-15
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse was able to reproduce the reported issue. The fse replaced the surgeon side console (ssc) footrest assembly to correct the reported problem. The system was tested and verified as ready for use. Isi received the ssc footrest assembly and completed the device evaluation. Failure analysis investigations replicated/confirmed the reported failure. The camera pedal got stuck when pressing on it. A review of the site's system logs for the reported procedure date was conducted by an isi technical support engineer (tse). The tse was unable to identify any errors related to the reported incident. In addition, a review of the site's complaint history identified no other complaints related to this reported event. No image or video clip for the reported event was submitted to isi for review. Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to another da vinci surgical system. Although there was no patient harm reported, if the alleged malfunction were to recur it could cause or contribute to an adverse event. 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.
 
Event Description
It was reported that during a da vinci-assisted hiatal hernia surgical procedure, the customer contacted intuitive surgical, inc. (isi) technical support to report that the camera pedal on the surgeon side console (ssc) was in the down position. The technical support engineer (tse) asked if the camera pedal was activated and only allowing the surgeon to move the camera arm, and the surgeon got on the phone and confirmed that the camera pedal was activated, and that he must press his foot against the side of the camera pedal and lift his foot to lift the camera pedal so that he could take control of instruments. The tse reviewed the system logs and found no related errors. The site continued with the case. The customer called back in for technical support. The tse noted that the site had two other systems, and one was a dual-console system. The tse confirmed all three systems were at the p9e software version. The tse informed the customer that they could replace the ssc during this case. The customer would check with the surgical staff and call back. The robotics coordinator called back in for technical support. The site had moved another ssc into the operating room. The tse had the site power down the system and move the blue fiber cable from the original ssc to the new ssc. The site powered on the system, and it powered up successfully. The robotics coordinator then reported that their stryker monitor had color bars. The tse informed the robotics coordinator that the issue was likely related to the video output signal from the original ssc. The tse confirmed with the robotics coordinator that they had one digital video interface (dvi) cable connected to the personality module surgeon console (pmsc). The tse recommended to remove the dvi cable from the original ssc and connect it to the new ssc, but the robotics coordinator was having a hard time removing the dvi cable at that time. The site continued the case with the vision side cart (vsc) touchscreen monitor as their bedside display. The robotics coordinator informed the tse that they would try to swap out the dvi cable and call back if needed. The procedure was converted to another da vinci surgical system with no reported injury. Isi performed follow-up with the customer on 30-june-2021 and obtained the following additional information regarding the reported event: the system was reportedly inspected prior to use, and no issues were noted at that time. The system initially powered on with no errors. The issue occurred about 35-40 minutes into the procedure. No patient-related information was available.
 
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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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12177936
MDR Text Key265641874
Report Number2955842-2021-10797
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 health professional,other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 06/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-15
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2018
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

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