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

Model Number	48345W-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, a blue object approximately 2 mm in diameter was discovered inside the chest cavity.It was immediately after the sureform45 white fire.It was thought that part of the pusher used to push out the reload staple may have fallen off.The piece was retrieved same procedure, and the procedure was completed as planned.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: the fragment was removed through the assist port.They visually confirmed all fragments were retrieved.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the provided image was performed, and the following additional information was provided: pusher colors for each sf45 reload color are as follows: black reload ¿ yellow pushers, blue reload ¿ orange pushers, green reload ¿ yellow pushers, white reload ¿ blue pushers.It looked like the user fired a white sf45 reload.As white reloads have blue colored pushers, it¿s possible the blue fragment pictured was generated from a pusher.Based on the image, it does not appear to be a full pusher, but potentially a piece of a pusher.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The sureform 45 white reload was returned and failure analysis investigation was completed.The reported complaint could not be replicated or confirmed.Visual inspection found no pieces missing and no product issue was identified.Unrelated to the reported event, the accessory reload knife was found to have blade damage.The knife edge was indented.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The sureform 45 white reload was lost in transit during transfer for advanced failure analysis.Based on the initial analysis, and that no pieces were found missing from the components within the reload, the coding will remain the same.It's possible the reported blue fragment may have originated from another instrument or accessory used in the procedure.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD WHITE
• 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: 20139292
• Report Number: 2955842-2024-18459
• Device Sequence Number: 19639911
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(10)K10230525
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48345W-01
• Device Catalogue Number: 48345W
• Device Lot Number: K10230525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/18/2024; 12/13/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/12/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose