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

Model Number	470500-13
Medical Device Problem Codes	Material Fragmentation (1261); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the universal seal to perform failure analysis.Fa was able to confirm the reported complaint the seal was found to have torn at the septum, measuring approximate 5.50 mm in length.The component was damaged and there may be missing material, was not returned with the accessory.The probable root cause of the torn seal is attributed to damage during various handling points, including installation or use.
Event or Problem Description
It was reported that during a da vinci assisted surgical procedure, the universal seal had air leak.There is no additional information available.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was unknown if the event resulted in sudden/rapid of insufflation.A backup universal seal was used for the procedure with no patient injury or 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: 24858918
• Report Number: 2955842-2026-21300
• Device Sequence Number: 21455935
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• UDI-Public: (01)10886874116408(10)K12250619
• 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): 05/18/2026

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: K12250619 NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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