MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE

Model Number	430073-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer observed that the access port wound retractor large ring broke off during reposition.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: according to the customer, the incident resulted in a loss of pneumoperitoneum due to an access port issue; however, there was no injury to the patient as a result of the reported failure.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The access port would retractor was analyzed and found to have a broken clamp.The broken component was returned.No missing component was observed.The complaint regarding the large ring broke off during repositioning was confirmed by failure analysis.The probable root cause of the broken tab is attributed to damage during use.

• 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: 22636552
• Report Number: 2955842-2025-31429
• Device Sequence Number: 21147464
• Product Code: NAY
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430073-05
• Device Catalogue Number: 430073
• Device Lot Number: U81240411
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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
• Patient Sex: Unknown