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

Model Number 380652-33

Device Problem No Device Output (1435)

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

Event Date 03/21/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted umbilical hernia etep surgical procedure, the customer was unable arm #3 to recognize the endoscope.The customer stated the same issue happened two weeks ago.The customer attempted flipping the endoscope to either up or down, keeping the clip opened or closed, and reseating sterile adapter/endoscope with no success.The customer kept receiving messages to remove the instrument and occasional ¿over rotational limit warning¿ messages.Intuitive surgical, inc.(isi) technical support engineer (tse) was unable to review the system logs because the system was not connected to onsite.Tse asked the customer to disable arm #3 and to install the endoscope on another arm but the surgeon elected to convert the procedure to an open surgery.Isi followed up with the initial reporter (nurse) and confirmed that the open procedure was completed successfully with no injury to the patient.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.Fse inspected arm #3 and found no physical damages.The arm was tested with fse¿s instruments, endoscope check aid and the 30-endoscope from the customer.The arm accepted each instrument without any issues, and it functioned appropriately.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.This complaint is considered a reportable event due to the following conclusion: the surgeon converted the procedure to open surgery due to endoscope engagement issue on an arm.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: 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: 14150236
• MDR Text Key: 298928616
• Report Number: 2955842-2022-11140
• 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: Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-33
• 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: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2016
• 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