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

Model Number 380652-51

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 03/29/2022

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 reported complaint was confirmed based on the field evaluation.The fse replaced the distal setup joint (suj) and the universal surgical manipulator (usm).The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the components involved with this complaint but the device evaluation is still in progress.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Technical service engineer did verify the multiple hardware error 30 and 31199 instances during the low anterior resection performed on (b)(6) 2022 with the system (b)(4).This complaint is reportable due to the following: the customer aborted due to arm 2 errors on the patient cart.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/abortion.

Event Description

It was reported that prior to starting a da vinci-assisted low anterior resection the customer had multiple recoverable error entries for 31199.Technical support had the customer hard power cycle the system and the error returned.Technical support reviewed the logs and found multiple error pointing to arm2 and the distal setup joint (suj).The customer swapped to a second patient cart.There was no patient harm.Intuitive surgical inc.(isi) followed up to confirm that there is no patient demographic information available.No other information was available.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the universal surgical manipulator (usm) and distal setup joint (suj) involved with this complaint and completed the device evaluation.The usm was confirmed to have triggered error 319 but the issue was not replicated in testing.The usm unit was tested on an in-house system in normal mode with no triggered errors.The unit was also tested on a test platform were the direction test, cva, sensor checks, sine cycle, friction test and brake test all passed.Components will be replaced as a precaution.Also, the issue with the suj was not confirmed.The suj passed all testing on the test machine.According to the error log reports, the suj had experienced errors 321 and 40084 due to communication loss.Components will be replaced as a precaution.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 14246951
• MDR Text Key: 299401450
• Report Number: 2955842-2022-11299
• 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,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-51
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES