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

Model Number	430005-57
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive 6 mm single port medium-large clip applier instrument to perform failure analysis.The instrument was tested on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grip tips opened and closed properly.The instrument passed the clip test.The instrument was fully functional.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 6 mm single port medium-large clip applier instrument was not clipping.No fragment fell into the patient.The user completed the procedure and no known impact or patient consequence was reported.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The medium-large clip applier instrument was could not verify the customer reported event.The instrument was tested on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grip tips opened and closed properly.The instrument passed the clip test.The instrument was fully functional.The complaint was not confirmed by failure analysis.The probable root cause cannot be determined.

• 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: 22111976
• Report Number: 2955842-2025-23055
• Device Sequence Number: 19864205
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(10)K10230817
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: 430005-57
• Device Catalogue Number: 430005
• Device Lot Number: K10230817 0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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: 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: Unknown