MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-46

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

As of 8/27/2020, a review of the site's complaint history does not show any additional complaints related to this product.No images or videos were shared for the event and no additional system/technical review was required based on complaint.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse arrived on site and attempted to calibrate the column.This attempt failed, suggesting a bad encoder, as did the error 23008 that the customer had observed at the time of the reported issue.Given that the encoders are compared directly to each other, it is impossible to determine outright if the primary or secondary encoder is the culprit.The fse swapped out the axis 1 motor into which the primary encoder is integrated.The fse then attempted to calibrate again.Unsuccessfully.This indicated a faulty secondary encoder, which the fse swapped out and then the calibration passed.The axis 1 motor will be returned for failure analysis.The faulty encoder involved with this complaint is a field scrap item and will not be returning to isi for further investigation.Following service, the system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the axis one motor assembly associated with this complaint, but is currently pending failure analysis investigation.A follow-up mdr will be submitted upon completion of failure analysis.This complaint is a reportable event due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure being converted/aborted.Although there was no patient harm reported, if this issue were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported during a da vinci-assisted total benign hysterectomy the site encountered an error 23008.The technical support engineer (tse) noted that the site performed a couple emergency power offs (epo) of the system, but there was no change to the issue.The patient side cart (psc) was not docked, but ports were placed on the patient.The surgical staff was in the process of getting another psc out of another room.Intuitive surgical, inc.(isi) completed follow-up with the customer and confirmed that system functionality was normal during set up and the system powered on without errors.The site completed all troubleshooting steps after contacting technical support, but the issue was not resolved.The surgical staff converted to another psc since the initial psc was not functioning as expected.The customer confirmed that the procedure was completed robotically after converting to another da vinci psc.There was no reported patient injury nor has the patient has returned to the hospital due to post-operative complications.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

4310 - intuitive surgical, inc.(isi) received the axis one motor assembly associated with this complaint and completed its investigation.Failure analysis (fa) noted the unit was replaced in the field to troubleshoot the reported 23008 error, but the replacement did not fix the problem.The replacement of a faulty secondary encoder, however, did resolve the issue.The secondary encoder was a field scrap item and was not returned to isi for failure analysis.The axis one motor assembly was scrapped following the failure analysis evaluation.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10565215
• MDR Text Key: 240949064
• Report Number: 2955842-2020-10949
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-46
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 34 YR
• Patient Weight: 126