MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD GREEN

Model Number	48345G-01
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
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 reload and sureform stapler were analyzed and the issue was not replicated with the stapler but issues were noted with the reload.The reload was found to have lodged staples wedged in between the reload in front of the exposed knife.Visual inspection confirmed there were 5 lodged staples closer to the blade stopping point.The reload had been fully fired.There was also cartridge damage and blade damage to the knife observed.The reload cover was removed, the shuttle was pulled forward to allow access to the knife, and the knife was inspected and damage was found to the blade and the cartridge.The event was caused partially or wholly by the user of the device including sample handling.The reload was found to have a damaged under cover.The cover was bent in and misshaped from its original shape.In addition, the sureform 45 stapler instrument passed all tests that were performed.No product issue was identified with the instrument.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, customer reported that the lot could not be checked because the stapler load did not come off or was dirty.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred after the first fire, and the instrument initially worked.A rectal transection was being performed at the time of the event.The tissue was not calcified or exposed to radiation or chemotherapy prior to the procedure.There was no tissue tension or bunching.The customer noted that while attempting to remove the reload from outside the body following firing, it would not come off.The event did not involve a failure to fire or partial fire, nor did it involve tissue being pushed forward/dragged or the stapler jaws opening/releasing during the firing process.No staples were deployed unexpectedly.The stapling issue did not result in any malformed or unformed staples, exposed blade, staples missing from the staple line that fired, holes/gaps, or reload stuck to the tissue.No error messages were displayed.The surgeon did not encounter any obstructions, fire over an existing staple line, or experience any clamping issues.Buttress material was not used.There was no bleeding observed or unplanned tissue removal necessary.The procedure was completed robotically using a backup isi stapler.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD GREEN
• 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: 22040679
• Report Number: 2955842-2025-20132
• Device Sequence Number: 8781365
• Product Code: GDW
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(10)N/A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: 48345G-01
• Device Catalogue Number: 48345G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2020
• 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