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

Model Number 380677-12

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The isi field service engineer (fse) went on-site to replace the left master tool manipulator (mtm) on the system.The system was tested and verified as ready for use.Failure analysis received the mtm and replicated the reported issue.This mtm was inspected visually.Link 3 was observed to not be attached properly to link 2, which caused the belts on link 3 to become loose.Incorrectly machined link 3 was determined to be the cause of it becoming loose.The reported issue was confirmed based on the failure analysis investigation.No image or video clip for the reported event was submitted for review.A site complaint history review was performed and no related complaints were found for this product.The isi technical service engineer (tse) reviewed system logs during the initial troubleshooting, and confirmed the reported errors.Based on the information provided at this time, this complaint is being classified as a reportable event because system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.Although there was no patient injury reported, if the failure were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that prior to starting a da vinci-assisted hysterectomy surgical procedure, but after port placement, the left master controller on the surgeon side console (ssc) was not passing the self test.Prior to calling intuitive surgical, inc.(isi) technical support.The customer had power cycled the system, but the issue continued.The isi technical services engineer (tse) reviewed system logs and found error 22005 indicating homing errors for the left master tool manipulator (mtml).The tse asked the customer if anything was hindering or hitting the arm, and it was confirmed that nothing was.Another power cycle was performed, but the issue persisted.The tse then advised the customer that they could power down again and exercise the arm, or bring in another ssc.The customer opted to bring another ssc to continue with the procedure.Isi followed up with the customer and obtained the following additional information: the customer did not inspect or confirm that the da vinci system was operational prior to the procedure.The issue occurred at the beginning of the procedure, after the ports were placed.No patient-related information was available.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11683218
• MDR Text Key: 267879208
• Report Number: 2955842-2021-10412
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• 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: health professional,other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-12
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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 Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 54