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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, a partial fire occurred using a sureform 45 stapler instrument with a white sureform 45 reload, resulting in minor bleeding.The stapler instrument had successfully completed the firing of the first stapler reload, prior to the incident.The partial fire happened during the second attempt to staple a vessel, while performing vascular dissection.The tissue was not under any tension and there also was no tissue bunching.However, the tissue had previously been subjected to radiation or chemotherapy.The surgeon did not fire over an existing line.The following error messages appeared during the event, "blade may be exposed" and "tissue too thick to continue." the blade was indeed exposed.Although the staple line showed no holes or gaps, some staples were missing from the line.A minor amount of bleeding, described as "oozing," was observed along the staple line.The bleeding was managed with the application of pressure using cotton pads, and the patient did not require a transfusion.Upon inspection, the white sureform 45 reload was found to have staples remaining in the track.The anvil was then removed and the remaining staples were removed from the stapler reload.Although additional perivascular tissue required dissection due to the partial fire, the surgical outcome remained acceptable, and the procedure was completed robotically.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the white sureform 45 reload to perform failure analysis.The stapler reload was found to have the blade rotated within the knife track but was not exposed above the surface.Additionally, the stapler reload was found to have cartridge damage.The cartridge was damaged in between the knife track at the site of the blade rotation.A sapler log review shows the sureform 45 stapler instrument (lot #k14241024-0514) was installed on the system 12 times and fired 10 sureform 45 reloads (2 white, 1 black, 1 white, 1 black, 1 white, 1 blue, 2 white, 1 black, in that order).On installs 1, 4, and 6-12, the first clamp was successful, and the firings were each completed with no pauses for compression.On install 4, the system failed to detect the reload color and the user manually selected the black sureform 45 reload via the surgeon side console (ssc) touchpad.On installs 2 and 5, a white reload was loaded, however no clamping or firing was attempted.On install 3, the first clamp was successful, but was followed by a firing failure.The firing stopped at approximately 86% completion.The logs show an error code representing the firing failure.After the 12th install, the instrument was removed and not used in the procedure again.
Additional Manufacturer Narrative
Additional information: further investigation found the blade appeared to have stopped forward travel, close to the distal end.The 3 most distal pushers on either side had not been deployed yet.During rotation, the knife breached the right-side wall, deforming cartridge material into the pusher pocket.Procedure logs were reviewed and confirmed the firing force had exceeded the pre-determined threshold.The reload was disassembled for inspection of internal components.The reload was split in half and upon disassembly, it was noted that the shuttle knife seat was cracked damaged.It appears that during the firing, the knife rotated forwards and to the right, creating a score at the distal end of the knife seat from the cutting edge.The proximal face of the knife seat was also found to be broken, likely caused by the force from the base of the knife as it rotated forwards.The shuttle was fully broken to remove the knife.The knife foot was observed to be bent, due to dragging along the cartridge knife track; however, the cutting edge was free of major indentations.Damage to various reload components suggest that the reload may have encountered a high load towards the end of the firing.Firing across hard objects results in excess load on the shuttle and knife, leading to shuttle breakage, and allowing knife rotation within the knife track.Damage observed to reload components is likely related to excessive loading that can occur due to interactions with hard objects, such as a previous staple line, clips, or challenging tissue.Excessive loading is attributed to the user.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22070738
• Report Number: 2955842-2025-20937
• Device Sequence Number: 21166663
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(17)270731(10)K13240725
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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-03
• Device Catalogue Number: 48345W
• Device Lot Number: K13240725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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