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

Model Number	48230M-05
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the endowrist gray stapler reload accessory to perform failure analysis.Failure analysis investigations did not confirm the customer reported complaint.The accessory was analyzed and the reload could be installed on the orange installation tool without any issues.It was able to be installed onto the stapler's jaws without any issues using the installation tool.Additional observations : upon visual inspection, the reload appeared to be unused and unfired.The reload was found to have a missing staple.Due to the missing staple, a detached fragment was observed.This instrument was transferred to engineering or further investigations where the initial findings were confirmed.The accessory had a missing staple.The installation tool and removal tool were detached from the reload upon return.Both could be re-installed and removed from the reload without any issues.
Event or Problem Description
It was reported that the endowrist 30 gray stapler reload fell off the applicator before loading.There was no report of patient involvement.On 06/09/2025, intuitive surgical, inc.(isi) received fda manufacturer and user facility device experience (maude) database report (b)(4) stating: reload fell off applicator before loading.A new staple load opened to complete the procedure.Rma# [redacted].Intuitive surgical inc., (isi) followed up with the initial reporter and obtained the following additional information: customer mentioned that there was no patient injury.The staples and fragment(s) from returned accessory did not fall into the patient.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc., (isi) received following additional information from additional follow-up : customer confirmed that reported failure on gray endowrist stapler 30 reload accessory did not cause fragment to fall into the patient.The issue was that the reload fell off applicator before loading.It did not fall into the patient nor did it cause any patient injury.No further information was available.The probable root cause of the detached fragment cause by the missing staple is probably due to improper reload alignment during install, or due to mishandling outside of installation.

• 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: 22464231
• Report Number: 2955842-2025-29265
• Device Sequence Number: 21140011
• Product Code: GDW
• UDI-Device Identifier: 10886874121938
• UDI-Public: (01)10886874121938(10)U80231211
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: 48230M-05
• Device Catalogue Number: 48230M
• Device Lot Number: U80231211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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 Age: 65 YR
• Patient Sex: Male