MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; ACCESS PORT KIT

Model Number	430073-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the access port kit for failure analysis evaluation.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy procedure, a small white clip on the sp access port kit that attaches the bottom of the access port to the wound protector snapped.The breaking of the clip caused a rapid loss of pneumoperitoneum.The rapid loss of insufflation caused a temporary loss of vision and control of the instruments.No injury or patient harm was reported.No fragment fell in the patient.No bleeding was reported.No collisions with instrumentation occurred.The access port kit was replaced with a backup access port kit.Shortly after exchanging the access port kit, the same small white clip snapped again on the replacement.The breaking of the clip caused a rapid loss of pneumoperitoneum.The rapid loss of insufflation caused a temporary loss of vision and control of the instruments.No injury or patient harm was reported.No fragment fell in the patient.No bleeding was reported.No collisions with instrumentation occurred.The surgeon placed a large surgical clamp on the access port kit to hold the pneumoperitoneum and completed the case robotically.No photos or videos of the procedure are available for review.Both access port kits were inspected prior to use.The surgeon believes the torque/movement of the scope contributed to the small white clips breaking.This complaint captures the first access port kit that broke.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive has received the part associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of a broken access port to be related to the customer reported complaint.The access port was found to have a broken tab.The broken tab measures approximately 2.20mm x 5.40mm.The broken tab was not returned with the access port.

• Brand Name: DA VINCI
• Common Device Name: ACCESS PORT KIT
• 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: 22133390
• Report Number: 2955842-2025-23316
• Device Sequence Number: 12864009
• Product Code: NAY
• UDI-Device Identifier: 10886874119546
• UDI-Public: (01)10886874119546(10)U10250310
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430073-05
• Device Catalogue Number: 430073
• Device Lot Number: U10250310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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