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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 380677-24
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
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 replaced the surgeon side console (ssc) foot pedal, which resolved the issue. The system was tested and verified as ready for use. Isi received the part involved with this complaint and completed the device evaluation. Failure analysis (fa) investigation confirmed the reported issue. Fa observed that the top cover of the camera pedal was falling off. Both the yellow and blue pedals made noise when depressed. A review of the site's complaint history does not reveal any related complaints involving this product and/or this event. No image or procedure video was provided for review this complaint is considered a reportable event due to the following conclusion: the customer moved to the second surgeon side console (ssc) after the start of the procedure due to the camera pedal falling off. 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.
 
Event Description
It was reported that during a da vinci-assisted pancreaticoduodenectomy surgical procedure, the site was experiencing an issue with the robot camera pedal falling off of the surgeon side console (ssc). The caller stated that the surgeon moved to the second ssc to complete the procedure. The caller stated that they were continuing with the case. The technical support engineer (tse) viewed the live logs and noted no associated errors. The procedure was completed as planned with no reported injury. Intuitive surgical, inc. (isi) followed-up with the customer and obtained the following information: the initial reporter confirmed that the procedure was completed with the second ssc without any injury or harm to the patient.
 
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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 Key13967215
MDR Text Key297334206
Report Number2955842-2022-10830
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
Remedial Action Other
Type of Report Initial
Report Date 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-24
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2021
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: 03/31/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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