MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 30 WHITE RELOAD

Model Number	48230W-06
Medical Device Problem Codes	Positioning Problem (3009); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The white stapler reload was analyzed and the complaint was not confirmed by failure analysis.The unit was found with broken reload tail and the switch.The broken tail measured approximately 2.90mm x 10.00mm and was returned with the switch.Per engineering review, the initial findings were partially confirmed.The reload was found with a broken cartridge tail.Both the tail and metal switch, used to detect the reload color, were detached from the main body, and returned along with the reload.The reload was visually inspected and no significant cartridge damage was found aside from the broken tail.All staples were present and seated in their respective pockets.The switch had not been depressed into the tail.The switch was inspected and no damage was found.Evidence suggests the reload was not fired.Tail breakage along with lack of damage to the switch suggests a potential sharp angle of insertion into the instrument channel.It is likely that the sharp angle of insertion allowed the tail portion of the reload to interact with components at the back of the channel, rather than the switch.Proper use of the installation tool will ensure the reload tail and switch are aligned within the channel during seating and will prevent tail breakage.
Event or Problem Description
It was reported that prior to the start (pre-anesthesia) of a da vinci-assisted surgical procedure, the white stapler 30 reload did not close during setup.A backup was used to complete the procedure.No fragments fell into the patient's anatomy.The procedure was completing as planned with no delays.Isi followed up with the initial reporter and obtained the following additional information: the customer confirmed that the reload was not inserted, thus, no fragments fell into the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to the retention of foreign material.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 30 WHITE RELOAD
• 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: 21856828
• Report Number: 2955842-2025-15307
• Device Sequence Number: 18117438
• Product Code: NAY
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)U81240208
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211997
• 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): 04/02/2025

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
• Device Lot Number: U81240208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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