MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE

Model Number	430073-05
Medical Device Problem Codes	Break (1069); Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the connection point (metal part) between the bladder and the ring was found to be broken on the access port.This meant the bladder was no longer leak-proof.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was a single port cholecystectomy.The access port was not thoroughly inspected, but there was no significant/visible damage.There was a gas leak during the surgery (due to the defective port).No fragments fell in the patient.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the access port, however, intuitive surgical, inc.(isi) has not received the accessory for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) obtained the following information from the customer: the loss of insufflation (pressure) became weaker but did not completely disappear; it was not quick but steady.The reporter did not know if there was a loss of the pneumoperitoneum.The "metal part" is most likely the white particle that came off the incision port.There was no patient injury due to the issue.The procedure was completed with the help of the da vinci system.There was no conversion.
Additional Manufacturer Narrative
Failure analysis found the primary failure of broken access port chamber to be related to the customer reported complaint.The access port chamber was found to be broken.The tab on the ring was found to be broken.The size of the tab measures approximately 9.86mm x 10.53mm in size.The broken tab was returned.The probable root cause is attributed to damage during use.
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: 22719187
• Report Number: 2955842-2025-32758
• Device Sequence Number: 9206493
• Product Code: NAY
• UDI-Device Identifier: 10886874119546
• UDI-Public: (01)10886874119546(10)U10250325
• 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,Followup
• Report Date (Section B): 07/09/2025

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: U10250325 0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 08/29/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/29/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 92 KG