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

Model Number 380677-07

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

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - an isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the left master tool manipulator (mtm) to resolve the system issue.The system was tested and verified as ready for use.The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon's side console.One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).Intuitive surgical, inc.(isi) received the mtml involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the arm limp during power-up on the test system.A review of the site's system logs for the reported procedure date was conducted by technical support.Investigation revealed the following possible related system errors: system logs confirmed error 23013: pot to encoder fdfd error mtml 2 axis 4.No image or video clip for the reported event was submitted for review.A site history review was performed and no related complaints were found for the product.This complaint is reportable due to the following: it was reported that during an inguinal hernia repair the customer had the issues with the left controls on the surgeon console going limp.The customer had swapped out the patient cart prior to contacting technical support.The customer then swapped out the ssc to resolve the issue.The procedure was completed and there was no patient harm and no post-operative complications.However, system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.Blank mdr fields: follow-up was attempted, but the patient information was either unknown or unavailable.The expiration date for section expiration date is not applicable.Field implant date is not applicable because the product is not implantable.Information for the blank fields in initial reporter is not available.Field initial reporter also sent report to fda is blank because it is unknown if the initial reporter submitted a report to the fda.Device mfr.Date is blank because the manufacture date is not available as of the date of this report.Field recall (if recall number is given) is not applicable.

Event Description

It was reported that during an inguinal hernia repair surgical procedure, the customer had issues with the left controls on the surgeon side console (ssc) going limp.The customer had swapped out the patient side cart (psc) prior to contacting technical support.The customer then swapped out the ssc and the issue was resolved.The procedure was completed with no patient harm.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10814505
• MDR Text Key: 241258918
• Report Number: 2955842-2020-11183
• 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: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/15/2020

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: 380677-07
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: 67 YR
• Patient Weight: 93