MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MEDIUM-LARGE CLIP APPLIER

Model Number	430005-62
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.No site visit was performed as the issue was addressed with phone support.
Event or Problem Description
It was reported that during a da vinci-assisted thymectomy surgical procedure, the medium-large clip applier became stuck on the artery.The e-stop was pressed, and the release knob on the instrument was tried with no change.The technical service engineer (tse) recommended the customer to use the instrument disengagement button to release the motor pack and then try to open the jaws.Additional ports were placed to assist with the attempt to remove the instrument.The surgeon was able to remove the instrument by moving the clip enough using the tip of a laparoscopic stapler.Blood loss was minimal due to placing additional ports in the patient's chest.There was no damage to the artery.The procedure was completed robotically.

• Brand Name: ENDOWRIST SP
• Common Device Name: MEDIUM-LARGE CLIP APPLIER
• 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: 23595028
• Report Number: 2955842-2025-45583
• Device Sequence Number: 21208574
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(11)241212(10)K10241212
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• 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
• Report Date (Section B): 11/19/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 430005-62
• Device Catalogue Number: 430005
• Device Lot Number: K10241212 0021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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