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

Model Number	48345G-03
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted procedure, improper staple positioning was observed following a partial fire incident with a sureform 45 curved-tip stapler instrument, installed with a green sureform 45 reload.An error message, "tissue too thick to continue," was displayed at the time of the partial fire.Upon unclamping the jaws of the stapler instrument, the staples were found to be poorly placed within the tissue.After removal of the stapler instrument, the green sureform 45 reload remained lodged in the jaws and could not be removed.To resolve the situation, a monopolar curved scissors (mcs) instrument was utilized to complete the section.Additionally, the bronchial stump was manually sutured, and the procedure was successfully completed robotically.Additional information has been requested; however, no response has been received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.

• 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: 23477375
• Report Number: 2955842-2025-43698
• Device Sequence Number: 10252203
• Product Code: GDW
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(10)K13250508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: 48345G-03
• Device Catalogue Number: 48345G
• Device Lot Number: K13250508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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