MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST; STAPLE, IMPLANTABLE

Model Number	48645B
Health Effect - Clinical Codes	Failure to Anastomose (1028); Laceration(s) (1946)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Da vinci 45 stapler for a gastric bypass.Doctor fired a blue load staple and upon doing so, it cut the tissue however it failed to fire the staples leaving an open hole in the stomach.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 10626447
• Report Number: 10626447
• Device Sequence Number: 14111008
• Product Code: GDW
• UDI-Device Identifier: 00886874112878
• UDI-Public: (01)00886874112878(17)211031(10)L90191028
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2020
• Report Date (Section F): 09/02/2020

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: 48645B
• Device Lot Number: L90191028
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Weight: 110
• Date Report Sent to FDA: 09/02/2020