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

Model Number	470530-08
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The curved-tip 30 stapler instrument was further evaluated by failure analysis engineer (fae) and findings were partially confirmed.The procedure logs were reviewed and confirmed the instrument experienced multiple reload recognition failure in the field.The reload recognition failures are likely a result of the lodged staples found in the jaws, which short the dlu pins of the stapler.This shorting results in a failure to read the installed reload color.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis, and the complaint was confirmed.The curved-tip stapler 30 instrument was analyzed, and the instrument was visually inspected and found to have lodged staples in the jaws.Nine fully formed staples were noted at the distal end of the stapler inside the jaws, causing the reload to not attach to the instrument.The staples were removed, and nine were confirmed.Additional observation not related to customer reported complaint: the instrument was 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 is no longer intact.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.As a result, the grips will not open or close properly.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.The probable root cause of cable breakage, whether partial or full, is attributed to damage to the cable through external collisions, during use, or during reprocessing.A review of the information associated with this event has been performed by post market failure analysis engineer (fae) and the following additional information was provided: the logs showed that during the last use of the instrument, it was installed on the system 2x and fired 2 white reloads successfully.There were no errors pertaining to this instrument in the logs.We are unable to discern via the logs when the reload installation difficulties occurred, as that would occur while the instrument is off the system.It is very likely that a reload would not be able to fit into the channel of an instrument in this condition.If the reload was able to fully seat, the lodged staples would then likely prevent the system from detecting a valid reload, in turn preventing firing until the staples are cleared out.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the curved-tip stapler 30 instrument reload would not sit properly.The procedure was completed with no patient harm.

• 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: 24385662
• Report Number: 2955842-2026-04889
• Device Sequence Number: 21458860
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(10)T10201006
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 03/23/2026

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: T10201006 0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2020
• 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