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

Model Number 380652-46

Device Problems Visual Prompts will not Clear (2281); Defective Component (2292)

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

Event Date 02/22/2022

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 fse replaced universal surgical manipulator (usm) 2 to correct the reported issue "carriage was loose".The system was tested and verified as ready for use.Isi received the usm involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported failure for loose carriage.Upon investigation on insertion axis & carriage assembly, the bearing carrier on the linear rail fell apart causing the carriage assembly to wobble and not securing the instruments when installed.The unit was tested on the product functional test platform and passed all required tests.The insertion on the linear rail will be replaced to fix the reported problem.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed the following possible related system errors: 22020 pointing to installed vessel sealer extend failed to engage on usm 2.This complaint is being reported because an usm was abandoned after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.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.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, site reported that they were not able to insert an instrument with universal surgical manipulator (usm) 2 and the arm light emitting diode (led) would turn yellow.Prior to calling tech support, customer had reseated drape with no change and observed the carriage portion of usm2 where the sterile adapter engages was loose.Prior to calling customer had undocked usm2 and proceeded with usm1.Technical support engineer (tse) observed 22020 on usm2.The procedure was completed robotically with 3 arms with no patient injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 13876477
• MDR Text Key: 296810207
• Report Number: 2955842-2022-10738
• 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
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• 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