MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CURVED-TIP STAPLER 30

Model Number	470530-09
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The curved tip stapler instrument was analyzed and found to have a broken grip cable at the pivot tube.The cable was fully broken.The segment of the cable that contains the crimp was still intact upon initial inspection.The cable was tugged on to confirm the breakage, and was separated from the instrument during the inspection.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.Additional observation(s) related to customer reported complaint: the instrument was found to have two firing failures based on log review, which were not replicated through in-house testing.The stapler was placed on an in-house system and was unable to open.The broken grip cable did not allow operation of the jaws.Therefore, the stapler could not be tested for its firing capabilities.Common causes of broken - distal instrument grip cables, whether partial or full, are commonly attributed to damage to the cable through external collisions, during transport/storage, during use, or during reprocessing.The root cause of the failed fires is attributed to a broken grip cable.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.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, customer stated firing failed, error message - cannot complete firing cycle.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED-TIP STAPLER 30
• 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: 23529848
• Report Number: 2955842-2025-44721
• Device Sequence Number: 9083421
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(11)241017(10)T10241017(91)0001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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: 470530-09
• Device Catalogue Number: 470530
• Device Lot Number: T10241017 0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White