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

Model Number	48360W-08
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the sureform 60 stapler was broken with the clip on.There was no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the sureform stapler instrument associated with this complaint and completed investigations.Failure analysis investigations did not replicate nor confirm the customer reported complaint.Visual inspection did not reveal any damage.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument clamped and fired.No failures were found in the logs.The instrument was fully functional.No product issue was identified.Additionally, the sureform white reload accessory has been returned and evaluated by the failure analysis team.Failure analysis investigations replicated and confirmed the customer reported complaint.The reload was found to have loose staples lodged in the knife track.A tweezer was used to remove the lodged staple, and 4 was confirmed.Moreover, the reload was found to have cartridge damage.The reload cartridge had mechanical indentations from lodged staples.There was no material missing as a result.The reload was found to have blade damage at the distal end of the blade.The reload was not involved in a firing failure.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD WHITE
• 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: 21381855
• Report Number: 2955842-2025-00921
• Device Sequence Number: 8462130
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 48360W-08
• Device Catalogue Number: 48360W
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2020
• 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