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

Model Number	470500-13
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The universal seal has not been returned for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy procedure, a piece of rubber was found in the surgical field and removed.The event occurred after the camera was docked and instruments were inserted.Upon examination, it was confirmed that the rubber inside the universal seal was torn.The fragment was retrieved during the same procedure and was confirmed to be completely removed through visual inspection.No additional surgical procedures were required, nor were any post-operative tests such as x-rays or ultrasounds conducted to check for remaining fragments.The procedure was completed robotically without the need for a backup universal seal.Moreover, the patient has not had to return to the hospital due to post-surgical complications.
Additional Manufacturer Narrative
Updated fields: d9, h2, h3, h6, and h11.Device evaluation: the universal seal was received for failure analysis evaluation.The universal seal was found to have a tear on the black rubber duckbill.The torn piece was missing and was not returned with the seal.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22916024
• Report Number: 2955842-2025-36018
• Device Sequence Number: 14665711
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• UDI-Public: (01)10886874116408(17)270228(10)U10250224
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K181395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: U10250224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown