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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 Problems No Device Output (1435); Visual Prompts will not Clear (2281)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the surgeon reported not being able to control instruments in arm 3 and 4. Intuitive surgical, inc. (isi) technical support engineer (tse) had caller verify master tool manipulator (mtm) hand assignments at the surgeon console. Hand assignments were as expected. Tse noted right master controller errors 23030 and 23027 and that the user disabled the right master controller. Tse guided site through system restart, but errors on the right master persisted. Tse had site swap surgeon consoles. The system came up without errors and the surgeon was proceeding with the procedure. The procedure was completed with another da vinci surgeon side console (ssc) and there was no reported injury to the patient. On 09-dec-2021, isi contacted the robotic coordinator to obtain additional information about the complaint: patient information was requested, but was not provided.
 
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 right master tool manipulator (mtmr) on the surgeon side console (ssc) due to the reported issue. The system was tested and verified as ready for use following the service. Isi received the mtm involved with this complaint and completed the device evaluation. Failure analysis (fa) was able to reproduce the reported failure during calibration (via matlab). Opto button assemblies and gimbal grip pads will be replaced as a fix. The root cause of the customer's reported issue was determined to be component failure. A review of the site's complaint history shows no other complaints for other issues related to this product. 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 revealed multiple errors occurred during the surgical procedure that were related to the reported complaint. Error 23030 is counterbalance spring cable failure on mtmr, axis 2 and error 23027 is digital pot health status error, mtmr, axis 8 (grip). This complaint is being reported as a reportable event 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.
 
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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 Key13005401
MDR Text Key288387862
Report Number2955842-2021-11742
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
Remedial Action Other
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
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 Manufacturer12/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2021
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: 12/14/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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