MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci; SEAL

Model Number	470500-14
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted partial nephrectomy procedure, a rubber piece from a universal seal tore off and fell inside the patient.The customer confirmed that the fragment was retrieved and removed from the patient's abdomen during the same robotic procedure.No patient complications were reported as a result of the event.The procedure was completed as planned.Intuitive surgical, inc.(isi) has attempted to gather additional information regarding the reported event; however, no response has been received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the universal seal to perform failure analysis.The universal seal was analyzed and found to broken rubber gasket, the universal seal was found to have a broken rubber piece measuring approximately 0.16 in × 0.07 in.The broken piece was returned with the accessory, and no missing pieces were identified during visual inspection.No additional damage was observed on the accessory.

• 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 ; +1(408)523-2100
• MDR Report Key: 50857860
• Report Number: 2955842-2026-38956
• Device Sequence Number: 21345446
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• Combination Product (Y/N): N
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 470500-14
• Device Catalogue Number: 470500
• Device Lot Number: K16260521
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2026
• 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