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

Model Number	48345G-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the rubber piece at the end of the stapler tore and broke making the instrument incapable of being used.The procedure was completed with no reported injury.Intuitive followed up with the initial reporter and obtained the following additional information: customer was told that it malfunctioned in a surgery.The only details that the customer was given was that the instrument was not working properly.
Additional Manufacturer Narrative
The sureform 45 stapler has been returned and evaluated by the failure analysis team.The instrument was found to have the snake wrist cover torn.The tears measured roughly.39"-.14".Visual inspection displayed a missing piece measured 0.09" - 0.03".The event was caused partially or wholly by the user of the device including sample handling.The sureform 45 green reload was returned and analyzed.The accessory was returned with a complaint that rubber piece at the end of the stapler tore and broke making the instrument incapable of being used.There was no damage to the reload.There are no device related failures.The reload was return used and fired.It was proceeded with the instrument.Visual inspection displayed no signs of physical damage to the cartridge, knife, pushers or cover.There was no damage to the reload or its components.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD GREEN
• 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: 25238093
• Report Number: 2955842-2026-25812
• Device Sequence Number: 9725404
• Product Code: NAY
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48345G-01
• Device Catalogue Number: 48345G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2020
• 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
• Patient Sex: Unknown