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

Model Number	48345T-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The black reload has been returned and evaluated by the failure analysis team.The reload was returned with the shuttle and knife separated from reload.The reload was found broken.No pieces were missing.Test for sound was not able to be performed.Additionally, the reload was found to have blade damage at the distal end of the blade.The cutting edge did not exhibit any signs of corrosion that would have contributed to the blade damage.The reload was also found to have cartridge damage.The reload cartridge had mechanical indentations from exposed component.There was no material missing as a result.The complaint was not confirmed by failure analysis.A review of the stapler logs for the sure form 45 stapler associated with this event has been performed by an isi failure analysis engineer (fae).The following additional information was provided: logs show pn 480545-04, ln l16231109-0650, was installed on the system 8x and fired 8 reloads (1 black, 1 green, 1 white, 1 blue, 4 black, in that order).On install 1, the stapler failed to detect the reload color, and the user manually selected the black reload via the gui on the ssc touchpad.On installs 1-4, and 6-8, the first clamps were successful, and the firings were each completed with no pauses for compression.On install 5, the first clamp was successful, but was followed by a firing failure.The firing stopped at ~37% completion, after a duration of ~23 seconds.Peak firing force was measured at 694 n.After the 8th fire, the stapler was removed and not used in the procedure again.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, there was a sound and the black sure form 45 reload stopped halfway.The procedure was continued as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the stapler instrument did work.The target tissue was the lung.The event did not involve a failure to fire.The event did involve a partial fire.The event did not involve the stapler jaws opening/releasing during the firing sequence.The reload did not deploy staples unexpectedly.An error message stating the tissue was too thick to continue was generated.There were no malformed or unformed staples.The reload did have an exposed blade.There were no missing staples from the staple line.There were no holes/gaps from the staple line.The reload was not stuck to tissue.There was no bleeding observed on the staple line.There was no unplanned tissue removal due to the stapler firing failure.The surgeon used another black reload and completed stapling.

• 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: 21429029
• Report Number: 2955842-2025-01867
• Device Sequence Number: 19920745
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)K11231130
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48345T-02
• Device Catalogue Number: 48345T
• Device Lot Number: K11231130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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: Reuse
• 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
• Patient Sex: Prefer Not To Disclose