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

Model Number	48360B-08
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sureform 60 stapler misfired.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform a failure analysis.The reload and sureform stapler were analyzed and the reload was found to have lodged staples wedged in between the reload in front of the exposed knife.Visual inspection confirms there are at least 3 full lodged staples ahead of the blades stopping point, which can prevent the blade from progressing through the full firing trajectory.There was also cartridge damage and blade damage to the knife observed.The event caused partially or wholly by the user of the device including sample handling.Additional observation(s) related to customer reported complaint: the reload was found to have the knife exposed within the knife track.Log review confirms the reload was involved in a firing failure.The knife was exposed towards the distal end of the returned reload, which aligns align with the firing completion percentage displayed in the procedure logs.The reload was found to have cartridge damage.Cartridge damage was found in between the reload at the site of the exposed knife.The shuttle was fully deployed and the knife was inspected.There was damage found to the blade.The event caused partially or wholly by the user of the device including sample handling.The reload was returned with sureform60 stapler.The reload blade was found to have mechanical indentations.The reload cover was removed, the shuttle was pulled forward to allow access to the knife, and the knife was inspected.Damage was found to the blade.The event caused partially or wholly by the user of the device including sample handling.The stapler was found to have 1 firing failure based on log review which was not replicated through in-house testing.The stapler was installed onto an in-house system and fired on a test foam using two in-house blue reloads.The instrument fired successfully, and the resultant staple line was visually inspected.The cut-line appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.The complaint was confirmed by failure analysis.A blade-exposed icon and message will appear if the firing sequence is interrupted.The probable root cause of the firing failure can be attributed to various factors.These factors may include instrument damage, particularly in the wrist area, tissue condition (e.G., disease state and density), and foreign objects (e.G., metal clips) that can cause stapler firing forces to exceed the prescribed limit and subsequently result in a partial fire.

• 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: 21429154
• Report Number: 2955842-2025-01937
• Device Sequence Number: 19985075
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 01/24/2025

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-08
• Device Catalogue Number: 48360B
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2018
• 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