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

Model Number	48230B-06
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The stapler 30 blue reload had missing staples during visual inspection.Due to the missing staples, detached fragments are observed that are not returned with the reload.The reload was found to have a bent tail.The reload was found to have damaged cartridge at the proximal, distal and middle portion of the reload.The advance failure analysis engineer confirmed all initial findings.The reload was returned with missing staples, damage to the proximal sides of the cartridge body, and a ben tail.Damage found on the reload is consistent with improper reload installation.It is likely that at some point during installation of the reload, the installation tool was not used as intended, and the switch was not properly aligned within the channel.If not properly aligned within the channel, the reload tail may interact with the components within the instrument jaws and can become bent or damaged.Misalignment of the reload may also result in the channel interacting with the pushers on one side of the reload, which is the likely cause for the reported protruding staples.Damage to the cartridge body appears to be related to potential reload removal with an external tool.Reload removal may challenging if the reload is not properly aligned within the channel, the reload halves are forced into the same side of the channel, resulting in increased friction.The probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, staples were sticking out of the stapler 30 blue reload.The reload was loaded into the stapler and when the second cover was removed, the customer noticed staples sticking up out of the reload.The user completed the procedure and no known impact or patient consequence was reported.Intuitive followed up and obtained additional information.The procedure was an appendectomy, and a blue reload was used for the type of tissue.The issue occurred on the 1st fire, but it was never fired.The reloads were sticking out and the customer was instructed to return the staple reloads if they found the staples sticking out.The targeted tissue was the appendix.The tissue was not calcified.The tissue was not exposed to any radiation or chemotherapy prior to the procedure.There was not any tissue tension.There was not any tissue bunching.The issue did not involve a failure to fire.The event did not involve a partial fire.The event did not involve tissue being pushed forward/dragged during the firing process.The event did not involve the stapler jaws opening/releasing during the firing sequence.The event did not involve reload deploying staples unexpectedly.The stapler issue did not result in malformed or unformed staples.The reload did not have an exposed blade.There were no staple missing from the staple line.There were no holes/gaps observed within the staple line.There were no holes/gaps within the staple line.The reload was not stuck to tissue.There were no errors/messages generated when the stapling issue occurred.Buttress material was not used.The issue was resolved with a new reload.There are no photographic images of the device(s) or a video recording of the procedure available for isi review.

• Brand Name: SUREFORM
• Common Device Name: 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: 21403428
• Report Number: 2955842-2025-01635
• Device Sequence Number: 18201647
• Product Code: NAY
• UDI-Device Identifier: 10886874121914
• UDI-Public: (01)10886874121914(10)U80240808
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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: 48230B-06
• Device Catalogue Number: 48230B
• Device Lot Number: U80240808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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