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

Model Number	48360W-08
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 8mm sureform 60 stapler and the reload for failure analysis investigation.The instrument and reload were analyzed and the issue were not replicated with the stapler but issues were noted with the reload.The reload was found to have the staples lodged within the knife track.Visual inspection confirms there were 2 lodged staple(s) ahead of the blade stopping point, which can prevent the blade from progressing through the full firing trajectory.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 with the firing completion percentage displayed in the procedure logs.Additional observation(s) related to customer-reported complaints: 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 with the firing completion percentage displayed in the procedure logs.Visual inspection confirms there are 2 lodged staple(s) ahead of the blade stopping point, which can prevent the blade from progressing through the full firing trajectory.Common causes of the failure mode exposed component reloads are 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.The reload was found to have cartridge damage.The reload cartridge had mechanical indentations from the exposed component.There was no material missing as a result.The root cause is attributed to the user.The stapler was found to have qty 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 sheet using an in-house white reload.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.A review of the stapler logs for the two potential staplers associated with this event has been performed by an intuitive surgical, inc.(isi) fae.The following additional information was provided: logs show pn 480460-09, ln k10230915-0386, was used first, and it was installed on the system 4x and fired 4 reloads (1 blue, followed by 3 white).On install 1, the first clamp was successful, and the firing was completed with no pauses for compression.On install 2, the first two clamp attempts were incomplete, stopping at ~62% and ~65% completion, respectively.The third clamp attempt was successful, and the firing was completed with 1 pause for compression.On install 3, the first clamp was aborted by the user.The next 3 clamps were successful, and the firing was completed with no pauses for compression.On install 4, the first clamp was successful but was followed by a firing failure.The firing stopped at ~81% completion, after a duration of ~58 seconds.The peak firing force was measured at 566 n.The instrument was then removed and not used in the procedure again.Next, logs show pn 480460-09, ln k10230915-0395, was installed on the system 2x and fired 2 reloads (1 white, followed by 1 blue).On install 1, the first four clamp attempts were successful, however they were followed by a firing failure.The firing stopped at ~59% completion, after a duration of ~46 seconds.The peak firing force was measured at 604 n.On install 2, the first clamp was successful, and the firing was completed with no pauses for compression.The instrument was then removed and not used in the procedure again.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the sureform 60 stapler instrument stopped firing, and functioning, and would not unload during the procedure.The procedure was completed as planned with no reported injury.

• 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: 21369837
• Report Number: 2955842-2025-01440
• Device Sequence Number: 8563963
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/21/2025

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: 48360W-08
• Device Catalogue Number: 48360W
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/12/2025
• 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