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

Model Number	410370-03
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stapler sheath has been returned and evaluated by the failure analysis (fa) team.The sheath was found to have been damaged.There were tears measuring roughly.065".Visual inspection revealed missing material.A piece measuring approximately 0.64" x 0.16" was found to be missing.The logs were unable to verify any firing failures.The instrument was visually inspected and found to have lodged staples in the jaws.After removing the lodged staples from the jaw, the instrument was installed onto an in-house system and fired on a test sheet using an in-house 30 reloads.The instrument fired successfully twice and the resultant staple-line was visually inspected.The cut-line appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.No firing failure was observed.The instrument was returned without the reload for inspection; therefore, the reported complaint could not be replicated, and no firing failure was found in the dsp logs.The instrument was returned with sheath only.The instrument was visually inspected and found to have lodged staples in the jaws.Two fully formed staples were observed at the distal end the stapler within the jaws, preventing the reload from attaching to the instrument.The staples were removed, and two were confirmed.The instrument was found to have a reload recognition failures during in-house testing and based on log review.A golden reload was unable to be attached to the dlu pins due to lodged staples within the jaw.After removing the lodged staple from the jaw, the instrument was installed onto an in-house system and fired on a test sheet using an in-house blue ew 30 reloads.The instrument fired successfully twice and the resultant staple-line was visually inspected.The cut-line appeared smooth and consistent, with jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.The reload recognition failure was caused by lodged staples within the jaw.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.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 surgical procedure, the curved tip stapler 30 misfired.The reload was half deployed with blade exposed message.Stapler had 5 lives left.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: 25155493
• Report Number: 2955842-2026-24838
• Device Sequence Number: 13092304
• Product Code: NAY
• UDI-Device Identifier: 00886874111130
• UDI-Public: (01)00886874111130(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 410370-03
• Device Catalogue Number: 410370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/12/2026
• 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