MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; NONE

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
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the small white clip of the access port kit, wound protector accessory 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 did cause 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, wound protector accessory was replaced with a backup access port kit, wound protector accessory.Shortly after exchanging the access port kit, wound protector accessory 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 did cause 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, wound protector accessory to hold the pneumoperitoneum and completed the case robotically.No photos or videos of the procedure are available for review.Both access port kit, wound protector accessories were inspected prior to use.The surgeon believes the torque/movement of the scope contributed to the small white clip breaking.This complaint captures the second access port kit, wound protector accessory.The procedure was completed robotically with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received a product for failure analysis evaluation.A review of the site's system logs for the reported procedure date 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.Refer to manufacturer report 2955842-2025-23316 for documentation of the second breakage during the same procedure.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive has received the part associated with this complaint and completed investigations.Failure analysis found the primary failure of a broken tab to be related to the customer-reported complaint.Visual inspection was performed, and the access port was found to have a broken tab on the chamber retainer snap collar port.

• Brand Name: DA VINCI
• Common Device Name: NONE
• 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: 22131913
• Report Number: 2955842-2025-23315
• Device Sequence Number: 15546355
• 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): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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: Male