MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLACK

Model Number	48345T-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the stapler sureform 45 was observed to have stopped working halfway through the process.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no report of fragments falling from the device while used within a patient.The patient did not return to the hospital due to experiencing any post-surgical complications related to retention of foreign material.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The black reload was analyzed and found to have the knife exposed within the knife track.The reload was partially fired.The reload was found to have a firing failure during in-house testing.The reload was partially disassembled in-house for inspection.The reload was found to have cartridge damage along the knife track.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Additional analysis was performed on the reload by an advanced failure analysis (afa) engineer.Afa confirmed the initial failure analysis findings.The reload was returned partially fired and the reload knife was slightly protruding above the top surface of the cartridge.The knife stopped forward travel at approximately 30 percent of the knife track distance.The knife was observed to be rotated forward and slightly to the left, damaging the inner knife track and shuttle simultaneously.The shuttle assembly was removed for further inspection, and it was found that the knife had dislodged from its nominal position within the shuttle knife seat by rotating forward.The forward rotation of the blade caused the front part of the shuttle knife seat to split apart due to interaction with the cutting edge.Additionally, the forward rotation resulted in the knife base pushing backwards and breaking through the shuttle material proximally.Knife was removed and showed no damage to the cutting edge; however, a large indentation was seen to the right top side of the knife.It appears that knife material may be missing and was not able to be located amongst the reload.Evidence suggests that the knife may have experienced a high load from the top and/or right almost immediately after the firing was initiated which caused the knife to be pushed down/rotate.This resulted in the shuttle breaking, which allowed the components to drag along the knife track while being pushed further below the track.Further investigation of the inner knife track of the cartridge shows severe material deformation, beginning at the very proximal end of the track, and continuing until the failure point, about a third of the way into the travel distance.It is likely the deformation to the inner track material, skiving, and knife dislodgment resulted in a sharp increase force, leading to the partial fire.It is unclear, based on visual inspection, what caused the load to the top of the knife to instigate this chain of events.Cutting edge was free of mechanical indentations which does not support firing across an obstruction.As an additional note, fragments were generated from the broken shuttle; however, all fragments were retained within the reload.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLACK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 18976551
• Report Number: 2955842-2024-12839
• Device Sequence Number: 6665861
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)L10230413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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: 48345T-01
• Device Catalogue Number: 48345T
• Device Lot Number: L10230413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: ISIFA2022-02-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown