MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, RECERTIFIED

Model Number	380799-03
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted umbilical hernia etep surgical procedure, a recoverable fault continued to occur on universal surgical manipulator (usm) 4.The system was hard power cycled, but the error remained.The surgeon was able to continue the procedure by disabling usm 4.Tse remained online while the surgeon docked and started procedure.The procedure was completed as planned with no reported injury.Intuitive followed up with the initial reporter and obtained the following additional information.The issue was identified during the procedure and thus, ports were already placed when the usm 4 was disabled; the procedure was completed robotically with only 3 usms.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the universal surgical manipulator (usm).The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis.However, failure analysis is not complete.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h4 is not available.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The universal surgical manipulator (usm) was tested on an in-house system in normal mode where it triggered error 319.Errors 319 and 32097 were confirmed in the log.During the functional platform testing, the usm failed the fiber test due to a defective rolling loop fiber.

• Brand Name: DAVINCI XI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20652903
• Report Number: 2955842-2024-21739
• Device Sequence Number: 12823841
• Product Code: NAY
• UDI-Device Identifier: 00886874115497
• UDI-Public: (01)00886874115497
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: 380799-03
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2023-07-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Prefer Not To Disclose