MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI X/XISUREFORM 45 STAPLET RELOAD (BLACK) SUREFORM CURVED TIP 12 MM; STAPLE, IMPLANTABLE

Model Number	48345T VER 01
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During robotic thoracic surgical procedure, robotic stapling device did not fire completely.Outermost row of staples was still in the staple load after stapler fired resulting in small amount of bleeding at staple line.No error messages generated by da vinci system when stapler fired.New staple load opened and inserted into same staple gun.When surgeon attempted to use stapler, system responded that there was too much tissue between the jaws of the stapler.Surgeon repositioned stapler.Same error message received.Stapler removed from service.New stapler with new load opened and used without incident.Event reported to intuitive rep.

• Brand Name: DA VINCI X/XISUREFORM 45 STAPLET RELOAD (BLACK) SUREFORM CURVED TIP 12 MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 18174839
• Report Number: MW5148317
• Device Sequence Number: 15368990
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(17)250331(10)L11230330
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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 Expiration Date: 03/31/2025
• Device Model Number: 48345T VER 01
• Device Catalogue Number: 48345T
• Device Lot Number: L11230330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White