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

Model Number	470530-08
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endowrist 30 curved tip stapler has been returned and evaluated by the failure analysis (fa) team.The instrument was found to have imprecise motion.The instrument was installed on an in-house system and drive.The instrument exhibited imprecise motion in multiple directions.The grip tips did not move in the direction commanded.The main tube was inspected and found to have a broken proximal main tube tab.This tab mates with a slot in the medial seal, and breakage results in rotation of distal main tube.Rotation of the distal main tube separate from the proximal main tube should not occur.This tab is normally covered by the sheath during use.However, the tab was fully broken off from the instrument and not returned.Initial findings were confirmed.The instrument exhibits imprecise motion during system testing.The main tube was inspected and found to have a broken proximal main tube tab.This tab mates with a slot in the medial seal, and breakage results in rotation of distal main tube.Rotation of the distal main tube separate from the proximal main tube should not occur.This tab is normally covered by sheath during use; however, the broken tab was fully broken off from the instrument and was not returned.Probable root cause of main tube tab damage is attributed excessive loading applied to the distal end of the instrument.
Event or Problem Description
It was reported that the customer experienced an issue with an intuitive product.The customer reported event has no report of patient injury.Intuitive followed up with the initial reporter to obtain additional information, however, no further details are available regarding the reported event.

• 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: 24492953
• Report Number: 2955842-2026-14790
• Device Sequence Number: 16123427
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(10)T10191003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: 470530-08
• Device Catalogue Number: 470530
• Device Lot Number: T10191003 0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• 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 Sex: Unknown