MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD GREEN

Model Number	48360G-08
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The sureform 60 stapler was analyzed and found no damage.The instrument was tested on an in-house system.The instrument clamped, unclamped and fired successfully.A golden reload was installed and removed on 4 of 4 attempts without any failure.A review of the logs showed no errors.The instrument fully functional.No product issue was found.The sureform-60 green reload was also analyzed in failure analysis.The reload was found to have lodged staples wedged in between the reload in front of the knife.Visual inspection confirms there are two lodged staples ahead of the blade stopping point, which can prevent the blade from progressing through the full firing trajectory.There was also cartridge damage the complaint regarding unable to remove the stapler reload from the stapler was not confirmed by failure analysis.The probable root cause of the inability to remove the stapler reload cartridge upon using is attributed to the lodged staple observed.
Event or Problem Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the surgical tech was unable to remove stapler reload cartridge from the sureform 60 stapler after using.Several team members attempted to remove unsuccessfully.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter to obtain additional information, however, no further details are available regarding the reported event.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 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: 24230869
• Report Number: 2955842-2026-02478
• Device Sequence Number: 18437556
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2026

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: 48360G-08
• Device Catalogue Number: 48360G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2018
• 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