MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	48230W-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted appendectomy surgical procedure, the sureform 30 stapler reload tip broke off when inserting into stapler.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the reload was never used in the patient.Hence, no fragments were lost or retained.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the sureform 30 stapler reload to perform failure analysis.The reload was analyzed and visual inspection was performed and the reload was found to have a broken tail.The broken tail measured approximately 3.62mm x 8.58mm.The reload was not fired.The rma was returned with fragments of broken tail and switch, as well as another reload with a broken tail and missing switch.Additional observations that are related to the customer reported complaint: due to the broken tail, a detached fragment observed.The reload was found to have a missing switch.The switch measured approximately 2.68mm x 3.16mm in size.This failure is likely due to broken tail.Due to the missing switch, a detached fragment is observed.The reload was found to have damaged cartridge at the distal portion of the reload and a crack is observed at the proximal portion.Initial findings were confirmed.The reload was found with a broken cartridge tail.Both the tail and metal switch, used to detect the reload color, were detached from the main body.This reload was returned with an additional white reload and a single tail fragment.After inspection of the damage to both reloads, it was determined that the returned fragment is more likely to have broken off from rma 303292930010, rather than this reloads.Reload was visually inspected and an indentation was found at the lip of the cartridge towards the distal end.Indentation suggests a tool may have been used in attempts to pry the reload from the channel.Further inspection revealed all staples were present and seated in their respective pockets.It does not appear that the reload was fired.Tail breakage suggests a potential sharp angle of insertion into the instrument channel.It is likely that the sharp angle of insertion allowed the tail portion of the reload to interact with components at the back of the channel.Proper use of the installation tool will ensure the reload tail and switch are aligned within the channel during seating- 1 - and can prevent damage to the reload.The complaint was confirmed by failure analysis, which indicates that the device did contribute to the customer-reported issue.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER
• 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: 21887658
• Report Number: 2955842-2025-16388
• Device Sequence Number: 3553283
• Product Code: NAY
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)K11241212
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 48230W-06
• Device Catalogue Number: 48230W
• Device Lot Number: K11241212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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