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 the curved-tip sureform stapler 30 instrument and an associated white reload accessory to perform failure analysis.The accessory was analyzed and it was found to be unused and unfired.The accessory had a missing switch.The switch measured approximately 3.68 mm x 1.70 mm in size.Due to the missing a switch, a detached fragment was observed.The reload also had a missing staple.There was a cartridge damage on the tail part of the reload.Isi did receive the curved-tip sureform stapler 30 instrument to perform failure analysis.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.System messages like: "no valid reload detected" and "lockout detected" were observed for the 1st and 2nd installs.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: 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 was 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.On 05/15/2025, intuitive surgical, inc.(isi) received user facility report (b)(4) stating: stapler didn't recognize a new load as new.It said it was a reused load.Then we loaded it with a new load and attempted to fire it, and it fired part way then stopped and said the tissue was too thick.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.Patient demographics were requested but were unable to be provided.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The curved-tip sureform stapler 30 white reload accessory was re-evaluated by advance failure analysis team.The initial findings were confirmed.It was observed that the reload was returned with missing staples.Additionally, the switch of the reload was found to be dislodged from the reload tail and was not returned with the reload.There was cartridge damage near the switch location.The probable root cause of missing staples, damage to the reload tail, and missing switch at the proximal end, is attributed to the user.Based on the findings, it was 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 designed 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.Correct use of the installation tool ensures proper alignment of the reload within the instrument channel and helps prevent damage to its proximal end.

• 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: 22399492
• Report Number: 2955842-2025-28775
• Device Sequence Number: 8573774
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care 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
• Is the Reporter a Health Professional?: Yes
• 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: 07/03/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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