MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE

Model Number	430075-05
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the single-port (sp) access port kit involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted simple transvesical prostatectomy surgical procedure, the metal ring of the single-port (sp) access port kit became loose.There was no collision with any instruments.The customer used another sp access port kit to resolve the issue.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was a sudden loss of insufflation in the extraperitoneal space.The ring was a metal or silver color.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The access port kit accessory was analyzed and found to have the retaining ring dislodged inside of the reducer cap.The retaining ring appeared to be dislodged from its expected location which is in the groove on the cannula shaft.The cannula was inspected, and no damage was observed, specifically in the groove where the retaining ring sits.The retaining ring remained inside of the cap.There was no visible damage to the cap.The retaining ring secures the cannula to the top of the retaining base, and since the retaining ring is dislodged, the cannula is able to be removed from the rotating base which is not expected behavior.The complaint was confirmed by failure analysis.The probable root cause of the reported complaint can be attributed to a workmanship issue during manufacturing.When the retaining ring is not properly seated on the cannula shaft, the retaining ring can potentially become dislodged.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22929508
• Report Number: 2955842-2025-34554
• Device Sequence Number: 9079711
• Product Code: NAY
• UDI-Device Identifier: 10886874119553
• UDI-Public: (01)10886874119553(17)270331(10)K10250327
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: 430075-05
• Device Catalogue Number: 430075
• Device Lot Number: K10250327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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: Reuse
• 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