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

Model Number	470500-14
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the universal seal luer port where the insufflation tube connects was broken.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the da vinci product with an alleged issue to perform failure analysis.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The universal seal was analyzed and found to have an broken port at the lower housing.The broken piece measuring roughly 5.00 mm in length.Further inspection found no abnormally sharp or damaged components that could have contributed to the port breaking.The broken piece was not returned with the accessory and was missing.The complaint regarding a broken luer port was confirmed by failure analysis.The probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24781661
• Report Number: 2955842-2026-20392
• Device Sequence Number: 18651073
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• UDI-Public: (01)10886874116408(10)U11250818
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/05/2026

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: 470500-14
• Device Catalogue Number: 470500
• Device Lot Number: U11250818 NA
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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