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 02/19/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted proximal gastrectomy surgical procedure, the customer disinfected the dirty universal surgical manipulator (usm) 3 carriage with isodine solution.As a result, isodine leaked inside the arm discs, and the light emitting diode (led) indicator began to turn orange.Since the issue occurred at the final stage of the operation, the procedure was completed with the remaining three usms.There was no reported patient injury.After the procedure, the customer called the intuitive surgical, inc.(isi) technical support engineer (tse) for assistance.The customer also mentioned that the led on usm 3 turned amber after the drape was removed.The customer power cycled the system, but the issue was not resolved.The tse found error 31009 in the logs.The tse had the customer check the usm pin, which was stuck and not responsive.The procedure was completed.Isi followed up with the initial reporter and obtained the following additional/updated information: the customer stopped using and disabled usm 3.The procedure was completed with the remaining three usms.It was confirmed that there was no patient injury.

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 confirmed the reported complaint.The universal surgical manipulator (usm) pin was stuck due to isodine solution adherence.The fse replaced usm 3 to resolve the issue.The system was tested and verified as ready for use.Isi has received the usm for evaluation, but evaluation has not been completed as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.Review of the provided images are consistent with the alleged complaint: the arm disc area was contaminated.The root cause of the failure mode cannot be confirmed without the returned device.

• 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: 18904548
• MDR Text Key: 337672116
• Report Number: 2955842-2024-12294
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/19/2024

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: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2022
• 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.