MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-36

Device Problem Energy Output Problem (1431)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the customer observed that the e-100 generator would not recognize the vessel sealer extend (vse).The customer reported a check energy cord message when attempting to fire the vse.The leds on the generator appeared to be normal.The customer opened a second vse prior to calling and received the same message.The technical service engineer (tse) asked if the vse worked when connected to the erbe.The customer stated that they do work in the erbe.The surgeon opted to start the procedure using the erbe and did not want to power cycle the e-100 or the system.The customer continued with the procedure using the erbe.The tse attempted to review the logs but the system was not online at the time.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed there was no injury to the patient and the procedure was completed robotically.The customer stated the e-100 was not used for the remainder of the procedure and the issue occurred shortly after beginning the procedure.The e-100 did not work prior to the issue.The system and generator initially powered up without errors.Patient demographic information was requested but unavailable.

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 found that the e-100 would not power down.When plugged in there is a solid white light emitting diode (led) and solid white power button but no response when the power button was pressed.The fse replaced the e-100 generator to resolve the issue.The system was tested and verified as ready for use.Isi received the e-100 involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated and confirmed the reported failure regarding the e-100.The unit was installed into the test system and it failed.The power on/off led remained solid on and the unit could not be turned on or off by pressing the power button.A review of the site's complaint history does not reveal any related complaints involving this product and/or this event.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.No image or procedure video was provided for review.This complaint is considered a reportable event due to the following conclusion: the electro-surgical generator unit (esu) was replaced after the start of the procedure and the surgeon was able to continue with the procedure robotically with a backup esu.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 conversion/abortion.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 13944226
• MDR Text Key: 289345843
• Report Number: 2955842-2022-10814
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-36
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2019
• 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
• Patient Sex: Female