MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE

Model Number	430073-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the bedside assistant tried to push the airseal port deeper in to get better smoke evacuation.The chamber detached from the access port grip and insufflation was lost.It was at the completion of the robotic portion, so the team undocked, completed the dissection (only about 1 cm left at this point) and removed the specimen.Since the dissection was completed the way it was supposed to be, the surgeon and the teams do not consider this as conversion.The procedure was completed with no patient harm, no fragment fall and no delay.The patient did not experience any immediate post-operative complications prior to discharge.
Additional Manufacturer Narrative
A return material authorization (rma) was issued for the access port kit.Intuitive surgical, inc.(isi) has not received the product for failure analysis investigation.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Images were provided of the access port chamber detached.

• Brand Name: NONE
• 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: 21067191
• Report Number: 2955842-2024-23849
• Device Sequence Number: 11636194
• Product Code: NAY
• UDI-Device Identifier: 00886874119549
• UDI-Public: (01)00886874119549(17)250531(10)U80230516
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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: 430073-02
• Device Catalogue Number: 430073
• Device Lot Number: U80230516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2023
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White