MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30 RELOAD GREEN

Model Number	48630G-04
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Failure analysis investigations replicated/confirmed the customer-reported complaint.The reload was found to have the knife exposed within the knife track.A firing failure was found based on log review and during in-house inspection.No damage was found to the knife blade.The complaint was confirmed based on failure analysis, which indicates that the device may have contribute to the customer reported issue.A review of the logs for the stapler 30 curved tip associated with this event has been performed by an intuitive surgical, inc.(isi) advanced failure analysis (afa) engineer.The following additional information was provided: curved-tip stapler 30 instrument (part number: 470530-08, lot number: t10230621-0023) was used first.It was installed on the system two times and fired two reloads (1 white, followed by 1 green).On the first install, both clamping and firing were completed successfully.On the second install, the first clamp was successful, but was followed by a firing failure.The firing stopped at 51% completion and logs show error code 22030, representing the failure.The instrument was then removed and not used again in the procedure.Next, the site used a second curved-tip stapler 30 instrument (part number 470530-08, lot number t10230322-0023) was installed on the system two times and fired two green reloads.On the first install, both clamping and firing were completed successfully.On the second install, the first clamp was successful, but was followed by a firing failure.The firing stopped at 40% completion and logs show error code 22030, representing the failure.The instrument was then removed and not used again in the procedure.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer encountered a partial fire with the curved-tip stapler 30 instrument.A green reload was installed inside the instrument.Error message displayed was ¿blade may be exposed¿.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use and no damage was noted.The issue occurred on the second stapler fire.The surgical task being performed was stapling.The target tissue was an artery.The tissue was not exposed to any radiation or chemotherapy.The tissue was not calcified.There was no tissue tension and no tissue bunching.The customer confirmed the issue was failure to complete the firing cycle and the instrument partially fired.The blade was exposed.The reload was not stuck to tissue.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws.There was no buttress material used.There were no clamping issues prior to firing.There was no observed bleeding.There was no unplanned tissue removal.The backup stapler had the same issues.They were unable to tell if staples were missing from the staple line that fired due to the misfire.The procedure was completed robotically using a third stapler.
Additional Manufacturer Narrative
Failure analysis investigations confirmed but did not replicate the customer-reported complaint for the curved-tip stapler 30 instrument (part #470530-08; lot #t10230621-0023).The instrument was found to have a firing failure based on log review.The instrument was placed and driven on an in-house system.The instrument passed initialization.The instrument moved intuitively with full range of motion in all directions.The jaw opened and closed properly.The instrument clamped, fired, and unclamped without any issues.The curved-tip stapler 30 instrument was found to have a lodged staple on the dlu pin at the distal end.Failure analysis also received the sheath associated with this stapler instrument and no damage was found.Failure analysis investigations confirmed but did not replicate the customer-reported complaint for the curved-tip stapler 30 instrument (part #470530-08; lot #t10230322-0023).The instrument was found to have a firing failure based on log review.The instrument was placed and driven on an in-house system, where it passed initialization.The instrument moved intuitively with a full range of motion in all directions.The jaw opened and closed properly, and the instrument clamped, fired, and unclamped without any issues.Failure analysis also received the associated sheath and no damage was found.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD GREEN
• 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: 18499421
• Report Number: 2955842-2024-10036
• Device Sequence Number: 7863870
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M11230126
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: 48630G-04
• Device Catalogue Number: 48630G
• Device Lot Number: M11230126 0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White