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

Model Number	48345T-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the black sureform 45 reload to perform failure analysis.There was no damage to the stapler reload.The stapler reload was returned unused and unfired.A visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.The reload was attached to an in-house golden instrument and placed and driven on an in-house system.The stapler reload attached to and removed from the instrument without any issues on multiple attempts.The instrument passed the recognition and engagement tests.The instrument initialized, clamped, fired, and unclamped without any issues using the returned stapler reload.The stapler reload cover was removed and inspected after firing, and there was no damage to the reload or its components.No product issue was identified.Isi received the sureform 45 stapler instrument to perform failure analysis.The instrument was found to have i-beam sleeve damage.The instrument was placed on an in-house system and found to fail initialization on 3 of 3 attempts.The instrument was found to have a high drivetrain friction initialization failure based on log review and during in-house testing, preventing the stapler from entering into following.A stapler log review for sureform 45 stapler instrument, (lot #l18250213-0150), was installed on the system 8 times and fired 6 sureform 45 reloads (5 blue, followed by 1 green).On installs 1-3, all clamps were successful, and the firings were each completed with no pauses for compression.On install 4, the firing was completed with 1 pause for compression.On install 5, the first clamp was successful, but was followed by a firing failure.The firing stopped at approximately 54% completion.On install 6, the first clamp was successful, but was followed by a firing failure.The firing stopped at approximately 74% completion.On the next two installs, the stapler failed to initialize with the system.Parameters of the errors indicate that high drivetrain friction was detected in each case.There were stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy procedure, a partial fire occurred involving a sureform 45 stapler instrument with a black sureform 45 reload, and there was some unexpected bleeding.The partial fire occurred during the third firing event, and the stapling stopped midway through the lung tissue.The surgeon was able to safely open the jaws and removed the instrument from the tissue with no injury to the patient.Throughout the procedure, there was a total blood loss of approximately 50 ml, which was slightly higher than anticipated but did not concern the surgeon.To resolve the bleeding, knitted surgicel (a 3rd party manufacturer product) was applied to the staple line and subsequently removed before the closure of the procedure.The procedure was completed without any further complications.

• 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: 22089064
• Report Number: 2955842-2025-21512
• Device Sequence Number: 15184910
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: 48345T-01
• Device Catalogue Number: 48345T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 142 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White