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

Model Number	48630W-04
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.Intuitive surgical, inc (isi) did not receive the white stapler 30 reload or the endowrist 30 curved-tip stapler instrument that were used during this reported event; therefore, failure analysis investigations could not be performed.A stapler log review showed the endowrist 30 curved-tip stapler instrument, (lot #t10210617-0043) fired 2 white stapler 30 reloads.On the first install, the firing was completed without any errors.On the second install, the first 3 clamp attempts were aborted by the user.The fourth clamp was successful, and the firing was completed without error.The instrument was then removed and not used again in the procedure.There were no stapler related errors in the logs.Refer to mfr report number 2955842-2024-20949 for additional information regarding the other white stapler 30 reload.
Event or Problem Description
It was reported that during a da vinci-assisted left pulmonary lobectomy procedure, there was bleeding due to an incomplete staple line where the surgeon had fired 2 white stapler 30 reloads with an endowrist 30 curved-tip stapler instrument.The stapler instrument was inspected prior to use, and there were no issues noted.During the firing process, the stapler reload deployed staples unexpectedly, causing holes and gaps within the staple line; and tissue was cut.The surgeon did not encounter any obstructions or material between the instrument jaws, and no error messages were displayed.The amount of bleeding is unknown; however, the patient did not require a transfusion of any blood products.The bleeding occurred from a vein in the left upper lobe and the s1+s2 artery; and was resolved with compression of the vein, use of hemostatic agent(s), and using a third-party stapler instrument.The procedure was converted to open surgery due to the stapling issue, and was completed.The patient tolerated the conversion and there were no post-operative complications.

• 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: 20511201
• Report Number: 2955842-2024-20950
• Device Sequence Number: 7110555
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)K10230907
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: K10230907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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