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

Model Number	48345T-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, it was noted that after attaching and using the sureform 45 black and white reloads, the plastic parts on both sides of the attachment site fell off and into to the patient.The fragment(s) were retrieved during the same procedure.There was no instrument collision.
Additional Manufacturer Narrative
The black reload was received and the failure analysis investigation was completed.The reload was found to have a lodged staple wedged in between the reload.Visual inspection confirmed there was one lodged staple at the distal end of the reload.The staple was removed, and the reload was inspected.There was cartridge damage and blade damage to the knife.The cartridge was damaged between the knife track at the site of the lodged staple.There were missing pieces of the cartridge that were not returned.The reload parts were separated for inspection, and damage to the blade was confirmed.The reload blade was found to have mechanical indentations.Medwatch report (2955842-2025-34954) was submitted for the sureform 45 white reload.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The stapler sureform instrument was returned with stapler reload was placed and driven on the in-house system.The instrument passed initialization.The instrument passed the recognition and engagement tests multiple times.The instrument moved intuitively with full range of motion in all directions.The jaws opened and closed properly.The instrument clamped, fired, and unclamped successfully.The instrument was successfully fired with a sf 45 black reload.Visual inspection was performed and no damage was observed.Additionally, the instrument logs were thoroughly examined, indicating no instances of engagement, initialization or recognition failures associated with the instrument.The instrument was fully functional.No product issue was found.Based on the investigation results, customer reported issues may be due to other factors unrelated to the product.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLACK
• 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: 22860463
• Report Number: 2955842-2025-34953
• Device Sequence Number: 9313668
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(17)280229(10)K10250206
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 48345T-03
• Device Catalogue Number: 48345T
• Device Lot Number: K10250206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown