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

Model Number	48230B-06
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, customer reported that when the stapler load was first loaded on the 30 mm stapler it was found to have staples that appeared to be protruding (dislodged) from the load.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the instrument was not used on the patient therefore the questions do not apply since it was put to the side when they saw the staples protruding through the load.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The stapler reload has been returned and evaluated by the failure analysis team.Visual inspection was performed and the reload appeared to have protruding staples.The reload was returned unused and unfired.The reload was found to have missing staples at the proximal end.Common cause of this failure is attributed to the user.Due to the missing staples, detached fragments were observed.
Additional Manufacturer Narrative
Initial findings were confirmed.The reload was found with 4 staples missing from the proximal end.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 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.The missing staple are attributed to mishandling.Proper use of the installation tool ensures correct alignment of the reload within the instrument channel and prevents staples from deploying prematurely.
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: 22729468
• Report Number: 2955842-2025-32532
• Device Sequence Number: 8990081
• Product Code: NAY
• UDI-Device Identifier: 10886874121914
• UDI-Public: (01)10886874121914(10)K10250124
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/10/2025

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: 48230B-06
• Device Catalogue Number: 48230B
• Device Lot Number: K10250124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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