MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; SEAL

Model Number	470500-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis investigations did replicate and confirm the customer complaint "there was a popping sound, and fragments that appeared to be valve pieces came out".The seal was found to have torn at the septum, measuring approximately 4 mm in length.The component is damaged and there may be missing material, was not returned with the accessory.Image review: a review of the provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: the fae reported that from the images provided there does not appear to be any obvious damage or breakages visible.The visible components of the seal appear to be intact and due to image quality the object on the green tape cannot be identified.In the first image, the septum was not fully visible, so the fae could not say for sure if it was broken or not.Due to the image quality, it was not apparent what the "fragments attached to the back of the green tape" are.The luer fitting appears to be intact in the second image provided and there was no obvious damage visible.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the universal seal had a popping sound and fragments that appeared to be valve pieces came out.There are fragments attached to the back of the green tape in the photo provided by the customer.The procedure was completing as planned with no reported injury.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive followed up and obtained additional information.Procedure was completed with no patient harm.

• Brand Name: NONE
• Common Device Name: SEAL
• 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: 24848775
• Report Number: 2955842-2026-21245
• Device Sequence Number: 5663762
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• UDI-Public: (01)10886874116408(10)K11250625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 470500-13
• Device Catalogue Number: 470500
• Device Lot Number: K11250625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown