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

Model Number 380677-21

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The mtml was replaced to correct the reported problem.The system was tested and verified as ready for use.The mtml was returned to isi for failure analysis, and the reported failure of ¿error 23027 along axis 3¿ was able to be reproduced during sine cycle.The following parts will be replaced as a fix: axis 3 potentiometer, axis 3 counter balance potentiometer.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.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 the tse during troubleshooting with the customer.Investigation revealed the following possible related system errors: error 23008, 23013 and 23030, pointing to failures on surgeon console mtml.Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: the customer encountered repeated recoverable errors midway into the procedure, which progressed to a non-recoverable error.Upon power cycling and restarting the system, the errors were still reoccurring, causing the surgeon to disable the master tool manipulator (mtm) left and continuing the procedure using the mtm right with a bedside assist using laparoscopy.The procedure was completed with no injury to the patient.Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted total benign hysterectomy surgical procedure, the customer reported recoverable faults on the system that would not recover.The operating room operating room staff stated they successfully released tissue and removed instruments.The intuitive surgical, inc (isi) technical support engineer (tse) viewed on site logs and found errors 23008, 23013 and 23030 on surgeon console mtml.The tse asked the or staff to cycle system power but the recoverable fault returned on power up.The or staff attempted to recover the faults, but the faults returned.The surgeon disabled the master tool manipulator left (mtml) and had a table side assistant use a laparoscopic instrument as the left hand to continue the case robotically.The procedure was completed with no reported injury.Isi followed up with the reporter and obtained the following information.The issue occurred about midway into the procedure.The system gave a recoverable error.Subsequently, the force bipolar (installed on arm 3), which was grasping the uterus, had an unclamping failure and the surgeon could not move the instrument.The instrument was not in strong grip mode when the issue occurred.The surgeon removed the stuck tissue by wiggling it out and using suction from another instrument.The site did not use the instrument release kit (irk) to release the instrument grip.The system then had a non-recoverable fault and the site power cycled to recover the fault.Upon restarting, the system continued to give recoverable faults.The surgeon was given three options to continue the surgery: either to convert to laparoscopic techniques, to convert to open surgery, or disable the mtml and have the table side assistant use laparoscopic instrument as left hand to continue case robotically.The surgeon opted for the third option and the bedside assist held the forceps and camera laparoscopically while the surgeon controlled the master tool manipulator right (mtmr).The surgery was completed with no injury to the patient.There was no tissue cut to release the stuck instrument, no unexpected bleeding and no blood transfusions.The patient was recovering well.According to the reporter, the force bipolar forceps worked with no issues in the beginning of the surgery.There were no cautery issues or unclamping issues initially.There was no collision of the instrument or arms intraoperatively.The system and instruments were inspected before use and there was nothing out of the ordinary.Patient-related information was not able to be provided.

• 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: 11135709
• MDR Text Key: 238337267
• Report Number: 2955842-2021-10007
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/14/2020

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: 380677-21
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2020
• 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