MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; SEAL

Model Number	470500-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer suspected that a piece of rubber broke off from one of two universal seals and fell into the patient's body cavity.The customer retrieved the fragment using a robotic instrument during the same procedure.No post-operative diagnostic studies were performed and no additional surgeries were required.
Additional Manufacturer Narrative
The universal seal has not been received for failure analysis evaluation.A review of an image provided by the customer was performed: the fragment in the image appears to be a portion of a universal seal.Note: refer to medwatch report (mdr) with mfr.Report#: 2955842-2026-25198 for mdr submission of the event against the second suspected universal seal.

• Brand Name: DA VINCI
• 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: 25204089
• Report Number: 2955842-2026-25459
• Device Sequence Number: 15961408
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• UDI-Public: (01)10886874116408(10)K13251203
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 470500-13
• Device Catalogue Number: 470500
• Device Lot Number: K13251203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female