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

Model Number	48630W-04
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The curved-tip stapler 30 instrument and stapler 30 reload have been received.However, as of the date of this report, the failure analysis evaluation has not been completed.Review of the curved-tip stapler 30 logs show the instrument was installed on the system 5 times and fired 5 reloads (3 blue, followed by 2 white).On each install, the first clamp was successful, and each firing was completed without error.The instrument was then removed and not used in the procedure again.There were no stapler related errors pertaining to the use of this stapler found.A review of the site's system log for the reported date found no related system errors occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, bleeding was observed after stapling across the pulmonary artery using a curved-tip stapler 30 instrument and white stapler 30 reload.There was no staple line observed on one side of the vessel; it appeared to be completely cut.The staples were malformed.Pressure was held on the vessel for approximately 6-7 minutes.The surgeon placed two clips on the vessel and utilized a vessel sealer instrument to resolve the bleeding.A back-up stapler was then used.The estimated amount of blood loss was unknown; the patient did not require a blood transfusion.The patient was discharged two days later without further complications.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The white reload was returned used and the staples had been deployed.The reload was unable to be tested for firing failures due to being previously used.The reload cover was removed and visual inspection displayed signs of physical damage to the cartridge located between the cut line of the reload and on the outer edge of the reload near the cover.No damage was found to the knife, pushers, or cover.All staples had been deployed properly.No loose or lodged staples were found.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The curved-tip stapler 30 instrument associated with this event was received, no physical damage was observed, no product issue was identified and no failures were found in the logs.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 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: 19461716
• Report Number: 2955842-2024-15399
• Device Sequence Number: 6734938
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)K10231012
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48630W-04
• Device Catalogue Number: 48630W
• Device Lot Number: K10231012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 07/25/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/26/2024; 08/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose