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 02/14/2022

Event Type  malfunction  

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 replaced the e-100 generator as a precaution.The system was tested and verified as ready for use.Isi received the e-100 involved with this complaint and completed the device evaluation.The reported issue could not be replicated.The e-100 was installed into the test system and it worked fine with a synchroseal instrument.Synchroseal instrument was used with a saline dipped gauze in the jaws and yellow pedal was fired.Sync activations, cut/seal tests were performed about 100 times and e-100 worked fine without any issue.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 not reportable due to the following: the electrosurgical 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 and may lead to an injury due to the patient's inability to tolerate a conversion.

Event Description

It was reported that during a da vinci-assisted distal gastrectomy surgical procedure, the surgeon called and stated that they were unable to use the vessel sealer instrument with the e-100 generator.They had tried to power cycle the e-100 generator prior to calling in with no success.They were able to use the same vessel sealer instrument with the erbe generator.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was a 5-10 minute procedure delay, patient information was not provided.

• 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: 13791139
• MDR Text Key: 297047603
• Report Number: 2955842-2022-10627
• 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,Health Professional
• Reporter Occupation: Physician Assistant
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/14/2022

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: 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: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• 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