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

Model Number 380652-31

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the robotics coordinator contacted technical support after a procedure was completed and reported the system had an issue with arm 2.The surgeon stated he felt there was an issue with the left master tool manipulator (mtml) of the console (s/n (b)(4).The surgeon stated his left arm was sore and the stiffness was prevalent.There were no collisions internal or external were noted at the time the issue occurred.Customer indicated they did not check the remote center at the time of occurrence.The drape material was not checked either as the system was undocked at time of reporting.Error logs showed an unexpected set up joint (suj) movement on arm 2 which could indicate a potential arm collision issue.The procedure was completed with no patient harm.Intuitive surgical, inc.(isi) attempted follow-up to obtain additional information.However, no further details have been received as of the date of this report.

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 was able to reproduce the issue and replaced the master tool manipulator 2 (mtm2) to correct the issue.The system was tested and verified as ready for use.Isi received the unit involved with this complaint and completed the device evaluation.The mtm2 was returned for failure analysis, and the reported failure was able to be reproduced during sine cycle.The following parts will be replaced as a fix: axis 5 motor, axis 5 magnet cup and pitch shaft.There was no image or video clip submitted for review.A review of the site's system logs revealed the following possible related system error: error 100 ¿ set up joint (suj) moved without being clutched on arm2 suj distal wrist.An event verification confirmed the procedure was performed on the reported event date (b)(6) 2022 on system (b)(4).This complaint is considered a reportable event due to the following conclusion: the field service engineer (fse) replaced the master tool manipulator 2 (mtm2) after the start of the procedure due to the arm 2 being felt heavy and laggy to manipulate.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.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 15656380
• MDR Text Key: 307101836
• Report Number: 2955842-2022-14784
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-31
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES