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

Model Number	470530-09
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted transthoracic chest anastomosis esophagectomy surgical procedure, the endowrist 30 curved tip stapler moved in the opposite of the intended direction.The user completed the procedure with no further issue reported.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the endowrist 30 curved tip stapler to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The instrument's main tube was found dislodged at the distal end of the main tube at the flap where the laser mark artwork was located.As a result, the distal main tube was able to spin freely, separate from the proximal main tube.Common causes of the failure mode dislodged instrument main tube are attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Applying excessive force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal can also cause the instrument to become dislodged.Additional observation(s) related to customer reported complaint: the instrument was found to fail intuitive motion.The instrument was installed on an in-house system and driven.The instrument exhibited imprecise motion.The grip tips moved in the direction commanded; however, a lag or delay in the motion was observed.The root cause of this failure is attributed to a dislodged main tube.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Correction to h8 field - updated to initial use of device the probable root cause of a dislodged main tube is attributed to damage during use.When the roll gear tabs that mate with the main tube and provide a hard stop are damaged, the main tube can rotate independently of the roll gear.This rotation can cause a miscalibration between the master tool manipulator (mtm) and main tube.The probable root cause of the functional test failure issue is attributed to the main tube.

• 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: 23098263
• Report Number: 2955842-2025-38634
• Device Sequence Number: 18448036
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(11)241031(10)T10241031(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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: T10241031 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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 Sex: Unknown