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

Model Number 380652-49

Device Problem No Device Output (1435)

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

Event Date 03/28/2022

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.To correct the issue, the fse replaced the reported universal surgical manipulator (usm) 4.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) has received the usm, but the evaluation has not yet been completed.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted following the completion of the evaluation, and if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product.No image or procedure video was provided.The fse reviewed the system logs at the time of the call into technical support.The logs confirmed the reported error 22020.This complaint is being reported based on the following conclusion: a 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 procedure change.Use.

Event Description

It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, the monopolar curved scissors failed to engage on universal surgical manipulator (usm) 4 and the led was yellow.The intuitive surgical inc.(isi) technical support engineer (tse) reviewed the logs and found an error 22020 pointing to an engagement error on usm4.The tse instructed the caller (nurse) through all troubleshooting steps, however, the issue persisted.The surgeon agreed with tse suggestion to proceed with the surgery as a 3 arm system.The procedure was completed as planned with no reported injury.Per subsequent follow-up, the customer confirmed the procedure was successfully completed with the remaining three arms with no patient harm and a delay of one hour.

Manufacturer Narrative

Additional information can be found in the following fields: g3, g6, h2, and h3.Evaluation information can be found in the following fields: h6, and h10.Intuitive surgical, inc.(isi) has received the universal surgical manipulator (usm) 4 associated with this complaint and completed the device investigations.Failure analysis investigations confirmed but not replicated the customer reported complaint.The usm was tested using drape with the bipolar, large needle, sureform 60, vessel sealer instruments and had no engagement problems.When tested with an in-house system the usm passed normal mode.During remote fe log review errors 22020, 23007, and 22008 were noted.The usm passed all required test on pftp, except yaw sensors check.Gearboxes (5-9) & top plate will be replace as a precaution.During inspection on the carriage, dof 6 gearbox was hard when manually rotate.After finished testing the unit, while manually checking, all gearboxes rotated with no issues.Additional findings unrelated to return were also identified: the usm failed the yaw sensors check.An insertion back cover and the cannula bottom cover will be replaced as cosmetic issues.

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: 14230472
• MDR Text Key: 299374972
• Report Number: 2955842-2022-11273
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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: 380652-49
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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: Male