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	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The white endowrist 30 reload was analyzed and found to have a broken tail and a dislodged switch.Both components were returned with the reload and are not missing.Additional finding is the switch was found to be bent.Tail breakage, switch dislodgement and switch bending suggest a potential sharp angle of insertion into the instrument channel.It is likely that the sharp angle of insertion allowed the tail portion and switch of the reload to interact with components at the back of the channel, such as the lockout mechanism or lockout cover.The switch likely bent and was pulled out of the tail during attempts to seat the reload while it was misaligned within the channel.The complaint regarding broken metal part of reload was confirmed by failure analysis.The most probable root cause of the broken tail, bent switch, and dislodged switch are attributed to use.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, there was a broken metal part of the stapler 30 white reload use of the instrument was discontinued, and it was replaced to the backup.No fragment fell into the patient.The user completed the procedure and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was confirmed that no fragment fell into the patient.There was an issue after firing.The customer removed the instrument after firing.The customer removed the reload using a removal tool and found that the instrument jaws were difficult to open and close.The customer visually checked the jaws and found a metal piece at the base.As it could not be removed with tweezers, the customer attempted to remove the instrument by hitting it against the sterilization table.The metal pieces shown in the provided image fell out from the base of the jaws.The customer continued the same procedure using new instruments.There are no photos and/or videos of this event available for isi review.Patient demographics were requested but were unable to be provided.

• 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: 22593314
• Report Number: 2955842-2025-31370
• Device Sequence Number: 9179953
• Product Code: NAY
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)K10241205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: K10241205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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