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

Model Number	48345W-03
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It reported that during a da vinci-assisted right upper lobectomy procedure, the firing sequence of a sureform 45 curved-tip stapler instrument with a white sureform 45 reload, stopped midway across the superior pulmonary vein.An error message was observed stating, "tissue too thick to continue".Due to the high risk of hemorrhage, the procedure was converted to an open thoracotomy to safely remove the stapler instrument.The atrial orifice was secured, and upon removal of the stapler instrument, the vein was found to be partially transected and sealed.Details regarding the resolution of the issue or the patient's current condition remain unknown.Additional information has been requested; however, no response has been received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis; however, the failure analysis evaluation has not been completed.A review of the stapler log shows that the sureform 45 curved-tip stapler instrument was installed on the system 2 times and fired 2 white reloads.On install 1, the first clamp was successful, and the firing was completed with no pauses for compression.On install 2, the first clamp was successful, but was followed by a firing failure.The following unclamp event was shown as successfully completed.Approximately 2 minutes later, the grip release tool was detected on the instrument.The e-stop was not detected, so the error code was shown in the logs.As a result of the grip release, the stapler instrument was force expired by the system, represented by another error code.There were no additional errors pertaining to the use of the stapler instrument in the logs.
Additional Manufacturer Narrative
Updated sections: h2, h3, h6, h11.Device evaluation: intuitive surgical, inc.(isi) received the white sureform 45 reload for failure analysis.The stapler reload was found to have deformed staples lodged in the knife groove, with the blade rotated inside the cartridge track.The knife did not show any damage.The rotated blade is an expected result of a ¿tissue too thick to continue¿ firing failure.Additionally, the lodged staples in the knife groove caused the knife to rotate within the cartridge and became stuck in the inner side of the cartridge.Due to a lodged staple and knife rotation, the stapler reload was also found to have cartridge damage along the inner knife track.Additional information: isi received the sureform 45 stapler instrument for fa.The stapler instrument was functionally tested on an in-house system and achieved adequate compression on a test foam with a green sureform 45 reload installed.The instrument was placed and driven on an in-house system, and moved intuitively with full range of motion in all directions.The grips opened and closed properly.The stapler initialized, clamped, fired, and unclamped without any issues in both attempts.Additionally, review of the logs revealed that the emergency stop release was pressed which was a result of the white stapler reload issue.

• 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: 22895198
• Report Number: 2955842-2025-35229
• Device Sequence Number: 15677724
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(10)K10241128
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 48345W-03
• Device Catalogue Number: 48345W
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown