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

Model Number	430073-05
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The port kit accessory was analyzed and found to have the port dislodged.For clarification, the wound retractor kit was returned with all four of the of the access port chambers protective flaps dislodged.All four protective caps were returned.Additional observation(s) not reported by site: the wound retractor kit was found to have a detached fragment.This code was added as a result of the protective flaps of the access port chamber becoming dislodged.All four protective flaps were returned.The wound retractor kit was found to have the protective flaps of the access port chamber cracked.Three out of the four flaps were found to be cracked at the latch.There was no material missing.The access port chamber was found to have a tear on the access port seal.The tear measured approximately 7.14mm in length.There was no material missing.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the nurse opened up and used a single access single port kit.When the suture went through fine, a part of the flap (yellow in color) popped off and fell into the patient.The staff was able to get it out of the patient.The procedure was completed.
Additional Manufacturer Narrative
On 03-feb-2026, intuitive surgical, inc.(isi) performed further investigation: the access port accessory was analyzed and found to have dislodged and damaged protective flaps, a torn septum seal, and a torn duckbill.The protective flaps, septum, and duckbill all resided at the same opening of the access port chamber which is typically referred to as the rotating access port seal.The rotating access port seal was inspected further; the 4 protective flaps were inspected, and 3 of them were found to be torn at the location that interfaces with the pucks within the seal subassembly.The pucks were inspected and appeared to be intact and properly assembled, as there were no abnormal gaps.Inspection of the underside of the seal subassembly where the flaps originated from (commonly referred to as the rotating access port seal) found a torn duckbill seal.The underside of the septum and the surrounding puck component appeared to have residual lubrication, potentially confirming that lubrication was applied to the area as expected during manufacturing.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23959580
• Report Number: 2955842-2025-50205
• Device Sequence Number: 5739505
• Product Code: NAY
• UDI-Device Identifier: 10886874119546
• UDI-Public: (01)10886874119546(10)K10251030
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 430073-05
• Device Catalogue Number: 430073
• Device Lot Number: K10251030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown