MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45

Model Number	470298-12
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted wedge-to-completion lobectomy surgical procedure, the stapler 45 instrument failed to deploy.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer did not have additional information to provide on the reported issue.
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 45 was analyzed and the complaint regarding a failure to deploy was not confirmed by failure analysis.Functional testing of the device in an attempt to replicate the reported complaint is not possible due to the returned condition of the device.A review of the logs did not show any firing failures.Further investigation confirmed additional observations.The instrument was found to have reload recognition failures based on log review and in-house testing.The instrument was found to have a broken grip cable at the distal end.There was no missing material.The instrument was found to have a broken conductor wire at the distal end.The instrument failed the electrical continuity test.The instrument was found to have a broken pivot pin at the distal end.The instrument was placed on an in-house system and failed during initialization.Signs of corrosion were found on the instrument bearings.Input disk bearings exhibit orange discoloration.System log investigation: a review of the stapler logs for the stapler 45 (470298-12/t10181019 0036) associated with this event has been performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: the last logged use of the stapler was on (b)(6) 2020.The fae provided a review of the stapler logs from that date as there were no logged uses on the reported event date of (b)(6) 2023.Logs show pn (b)(4), ln t10181019-0036, was installed on the system 6x and fired 2 green reloads.On installs 1, 3, and 5, the stapler failed to detect a valid reload as installed in the stapler.Three instances of error code 1164 show in the logs at time stamps correlating to the 3 install timestamps.On install 2, the green reload was manually selected by the user via the gui on the ssc touchpad.Clamping and firing on this install were completed successfully per the logs.On install 4, the green reload was manually selected by the user via the gui on the ssc touchpad, however no clamping or firing was performed on this install.On install 6, the green reload was manually selected by the user via the gui on the ssc touchpad.Clamping and firing on this install were completed successfully per the logs.The instrument was then removed and not used in the procedure again.There were no additional stapler related errors in the msc logs.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45
• 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: 17765287
• Report Number: 2955842-2023-18513
• Device Sequence Number: 6664770
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10181019
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• 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): 08/21/2023

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: 470298-12
• Device Catalogue Number: 470298
• Device Lot Number: T10181019 0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic