MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	48230W-06
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Upon visual inspection, the first white reload appeared to be unused and unfired.The reload was found to have missing staples.Due to the missing staples, detached fragments were observed.Advance failure analysis confirmed initial findings.It was observed that the reload was return with missing staples.Specifically, 2 proximal staples were absent from their designated pockets.No damage to the cartridge material was observed.The reload was not fired.Based on the missing staples at the proximal end, it is likely that during the reload installation process the installation tool was not used or became separated from the reload body during the process.This likely resulted in improper alignment of the reload tail within the instrument channel.The cartridge is design to have its two halves inserted on either side of the knife track.However, if the alignment within the channel is incorrect or if extreme angles of insertion are used, interaction with the channel or knife track of the instrument may result in a partial deployment of proximal pushers.The missing staples are attributed to the user.Proper use of the installation tool ensures correct alignment of the reload within the instrument channel and prevents staples from deploying prematurely.The second curved-tip sureform stapler 30 white reload accessory instrument has been returned and evaluated by the failure analysis (fa) team.The returned part was returned with a part failed component as an incidental return.The reload was returned with no reported issue.Upon visual inspection, the reload appeared to be unused and unfired.The reload was found to have a missing switch.The switch measured approximately 3.68mm x 1.70mm in size.Due to the missing a switch, a detached fragment was observed.The reload was found to have a missing staple.Due to the missing staple, a detached fragment was observed.The reload was found to have cartridge damage on the tail part of the reload.The curved-tip sureform stapler 30 instrument has been returned and evaluated by the failure analysis (fa) team.Failure analysis investigations confirmed but did not replicate the customer reported complaint.The instrument was found to have multiple reload recognition failures based on log review."no valid reload detected" and "lockout detected" were observed for the 1st and 2nd installs.Due to the returned condition of the instrument, functional testing was unable to be performed.Based on log review, the instrument was able to successfully clamp, fire, and unclamp for the 3rd install.No firing failures were observed.Additional observation not reported by site: visual inspection was performed and the instrument was found to have a lodged component in the instrument's reload channel.As a result, a reload is unable to be installed properly.
Event or Problem Description
It was reported that during a da vinci-assisted nephrectomy surgical procedure, the curved-tip sureform stapler 30 instrument did not recognize a new reload as new.The system displayed the reload was a reused reload.The user loaded the curved-tip sureform stapler 30 instrument with a new reload and attempted to fire, but the curved-tip sureform stapler 30 instrument partially fired and generated an error message that the tissue was too thick.The user completed the procedure and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the initial report was unable to provide any additional information about the reported event.
Additional Manufacturer Narrative
Initial findings were confirmed by advanced failure analysis for the stapler instrument.The instrument logs were pulled and the instrument was found to have experienced two reload recognition failure on the first installs during the procedure.The instrument was then successfully installed and fired.The firing failed at ~27% completion with a peak force value of 599 n.Visual and physical inspection was performed.There was a visible lodged component in the knife slot that was confirmed to be a fragment of a switch from a reload.Additionally, the knife on the driver had damage likely from the interaction with the switch component.There was no damage observed to the wedge.The root cause of failures in the field is related to the lodged switch fragment, which is attributed to improper reload installation.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER
• 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: 22582874
• Report Number: 2955842-2025-30854
• Device Sequence Number: 11887594
• Product Code: GDW
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• 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): 06/26/2025

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: 48230W-06
• Device Catalogue Number: 48230W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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