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

Model Number 380652-46

Device Problems Unintended System Motion (1430); Device Handling Problem (3265)

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

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) contacted the customer.No issues were found remotely regarding arm 3 freezing up.The fse went onsite to check for patient side cart swap and verified the system was working properly and the system was tested and verified as ready for use.A review of the site's complaint history does not reveal any additional complaints involving 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 isi technical support engineer (tse).Investigation revealed no related errors to the reported issue.This complaint is being classified as a reportable event due to the following conclusion: the customer converted to another console after the start of the procedure due to arm 3 freezing and locking up.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion.The cause of the reported issue remains unknown.

Event Description

It was reported that during a da vinci-assisted gynecological surgical procedure, the customer experienced arm 3 and the masters were freezing and locked up.The customer confirmed no errors or messages appeared, it was noted that the staff tried using a different instrument however the issue would return.The surgeon switched consoles and the issue persisted on the other console.The technical service engineer did not confirm any related errors in the logs.The procedure was able to be completed with no reported injury.On (b)(6) 2022, intuitive surgical, inc.(isi) contacted the initial reporter and additional information was obtained about the complaint: it was confirmed that the issue occurred during procedure, the customer stated they checked system functionality upon powering up the system.The customer confirmed the system powered on without any errors and there was no report of any external interference as the customer checked the drapes, checked the masters clearance and checked for arm collision.

• 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: 14069287
• MDR Text Key: 298580576
• Report Number: 2955842-2022-10997
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-46
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2019
• 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