MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE SURGICAL DAVINCI XI ENDOWRIST STAPLER 45; STAPLE, IMPLANTABLE

Model Number	48645W
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A (b)(6) year-old male patient, undergoing robotic assisted total abdominal colectomy.During procedure, the white vascular load misfired over the colic artery to the sigmoid colon.The stapler load partial fired and cut.There was a small amount of bleeding from the vessel.Surgeon placed a clip on vessel.Intuitive davinci xi surgical systems endowrist stapler 44mm reload reference # 48645w, lot # m90200831.Fda safety report id # (b)(4).

• Brand Name: INTUITIVE SURGICAL DAVINCI XI ENDOWRIST STAPLER 45
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 11207517
• Report Number: MW5098922
• Device Sequence Number: 17104534
• Product Code: GDW
• UDI-Device Identifier: 00886874112885
• UDI-Public: (01)00886874112885(17)220831(10)
• Initial Reporter State: MO
• 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): 01/18/2021

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: 08/31/2022
• Device Model Number: 48645W
• Device Lot Number: M90200831
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 58