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

Model Number	48360B-09
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform60 stapler instrument to perform failure analysis.The stapler instrument was analyzed and found to have one firing failure based on log review which was not replicated through in-house testing.The instrument had failed mechanical engagement during in-house testing with error code 22020 indicating that the roll hard-stop verification check failed.Isi did receive the associated sureform 60 blue reload to perform failure analysis.Failure analysis investigations replicated and confirmed the customer reported complaint.Based on logs review the partial firing was caused by the error of "tissue too thick to continue." the reload was found to have the knife exposed within the knife track.Log review confirmed that the reload was involved in a firing failure.The knife was exposed towards the distal end of the returned reload, which aligns with the firing completion percentage displayed in the procedure logs.Additionally, the reload was found to have an undeployed pusher on the proximal side.The probable root cause of an undeployed pusher on the reload is attributed to a component failure.
Event or Problem Description
It was reported that during a da vinci-assisted fundoplication surgical procedure, the system presented a "tissue was too thick" message while using sureform60 stapler instrument.It was noted that during firing sequence, the instrument had a blade sticking out in the middle.Customer replaced the instrument and procedure was completed with no reported injury.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD BLUE
• 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: 22346900
• Report Number: 2955842-2025-24266
• Device Sequence Number: 8527024
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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: 48360B-09
• Device Catalogue Number: 48360B
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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