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

Model Number 380652-54

Device Problem Failure to Sense (1559)

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

Event Date 02/16/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted abdominoperineal resection surgical procedure, operating room (or) staff contacted intuitive surgical, inc.(isi) technical support engineer (tse) and stated the site was not able to adjust the patient clearance up from the button on universal surgical manipulator (usm) 2.The customer stated that issue was noticed on (b)(6) 2024 and that the surgeon was able to complete the procedure.The customer stated that stowing the arms moved the patient clearance joint up and that the down button worked.The user completed the procedure using the same system.No known impact or patient consequence was reported.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was able to reproduce the issue.Investigation found that the tornado joint would move down, but not up.When stow used arm would move normally up.No associated error codes.Fse replaced the universal surgical manipulator (usm) 2 due to issue with tornado switch.Isi has received the usm, but failure analysis has not yet been completed.A follow-up mdr will be submitted after failure analysis investigation and if additional information is obtained.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the universal surgical manipulator (usm) involved with this complaint to perform failure analysis.The reported failure was confirmed and replicated.The usm was tested on an in-house system in normal mode where it triggered no errors, but the tornado up button did not work.The usm was also tested on a patient side cart fixture test platform (pftp) where it failed the insertion buttons test on tornado up.A golden insertion switch assembly was installed, and the usm passed the insertion buttons test.During the investigation, it was noted that there was lots of fluid intrusion on the insertion switch assembly and around the axes controller spar board (acsb) 3.As a fix, the insertion switch assembly will be replaced.Isi followed up with the initial reporter and obtained the following additional information: the system functionality was checked upon powering on the system and the system initially powered on without errors.

• 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: 18908658
• MDR Text Key: 337738591
• Report Number: 2955842-2024-12440
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-54
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White