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

Model Number 380652-31

Device Problem Difficult to Remove (1528)

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

Event Date 11/20/2023

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 event.The fse was able to reproduce the reported issue and replaced the universal surgical manipulator (usm) to correct the reported problem.The system was tested and verified as ready for use.Isi has received the usm; however, failure analysis has not completed their investigation.A follow-up mdr will be submitted when failure analysis has completed their investigation.

Event Description

It was reported that during a da vinci-assisted splenectomy surgical procedure, the customer contacted the technical support engineer (tse) and reported that an instrument was stuck on arm 1 of the patient side cart (psc).The customer was not able to remove the instrument with guidance, due to the ongoing procedure.The customer requested the field service engineer (fse) follow and possibly assist with removing the instrument.The tse recommended trying to remove the instrument using an allen wrench then inspecting and testing for proper engagement.The customer converted to a laparoscopic procedure.Intuitive surgical, inc.(isi) followed up with the customer and obtained additional information.The fenestrated bipolar instrument got stuck during a splenectomy procedure.There was a delay of approximately thirty minutes.The issue occurred during docking.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) obtained the following information from the site's robotics coordinator: the customer said they used 4 ports total and increased one port to 15 mm to insert a retrieval bag for the specimen.This would have reportedly occurred if the procedure was completed robotically as well.The patient tolerated the conversion.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

The universal surgical manipulator (usm) was returned and evaluated by the failure analysis (fa) team.The usm came in with a reported "cracked carriage" issue, which was confirmed via system logs and replicated in-house.The usm was tested on an in-house system in normal mode with no report errors.The usm was also tested on a patient side cart (psc) fixture test platform (pftp) where the fiber test failed for the clock spring and parallelogram fibers.Upon visual inspection, the top plate of the carriage showed physical damage.As a fix, the carriage will be replaced.

• 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: 18322861
• MDR Text Key: 330467701
• Report Number: 2955842-2023-21244
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

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: 380652-31
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/11/2023; 01/26/2024
• Supplement Dates FDA Received: 01/05/2024; 02/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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