MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS

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.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON 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 Key: 13005401
• MDR Text Key: 288387862
• Report Number: 2955842-2021-11742
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• 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 Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 380677-24
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 12/14/2021 Patient Sequence Number: 1

Treatment

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