MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER SHEATH

Model Number	410370-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The curved-tip 30 stapler instrument was analyzed, and the reported issue with the instrument could not be replicated nor confirmed.A visual inspection displayed no signs of physical damage.The stapler was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument fired successfully twice using a blue 30 endowrist reload.The cutline appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.The instrument passed the recognition and engagement tests on three out of three attempts.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument attached to and removed from the arm without any issues on multiple attempts.The instrument was fully functional with no problem detected.The sheath was analyzed and found to have damage.There was a torn piece missing measuring roughly 3.166" x 0.5170".The probable root cause based on failure analysis may be attributed to the observed damaged sheath, attributed to either sheath installation issues or damage during use.Tearing can be caused if the instrument is not completely straight when installing the sheath.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the curved-tip stapler instrument would not connect to universal surgical manipulator (usm) or the usm did not recognize the stapler.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER SHEATH
• 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: 23418344
• Report Number: 2955842-2025-43312
• Device Sequence Number: 18709385
• Product Code: NAY
• UDI-Device Identifier: 00886874111130
• UDI-Public: (01)00886874111130(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 410370-03
• Device Catalogue Number: 410370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2015
• 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 Sex: Unknown