MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 CURVED-TIP

Model Number	480545-06
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sureform 45 stapler instrument has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted thoracic procedure, a piece of a sureform 45 stapler instrument broke and fell into the patient.The stapler would not advance fully through the trocar and there was additional difficulty when attempting to remove the device.The stapler was not on tissue and was not used prior to being removed completely from the patient.Once removed, the team at the surgical field inspected the device and noticed a piece seemed to be missing from the "sheath" at the wrist of the stapler.The stapler was not being fired when the piece fell into the patient, and it did not fall during a collision.It was unclear how/if the fragment that fell into the patient was retrieved.An unspecified "other" post-operative test was performed.The procedure was completed as planned.On 09-feb-2026, intuitive surgical, inc.(isi) received user facility report (b)(4) stating: "during a robotic thoracic procedure, a disposable robotic stapler was being placed.The stapler would not advance fully through the trocar and there was additional difficulty when attempting to remove the device.The stapler was not on tissue and was not used prior to being removed completely from the patient.Once removed, the team at the surgical field inspected the device and noticed a piece seemed to be missing from the "sheath" at the wrist of the stapler.".

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 CURVED-TIP
• 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: 24313362
• Report Number: 2955842-2026-03196
• Device Sequence Number: 5676203
• Product Code: GDW
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(17)280831(10)K11250828
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K190999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 480545-06
• Device Catalogue Number: 480545
• Device Lot Number: K11250828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White