MAUDE Adverse Event Report: INITIATIVE SURGICAL DA VINCI XI SUREFORM STAPLER RELOAD; STAPLER LOAD

Model Number 48360T-08

Device Problems Defective Component (2292); Device Issue (2379)

Patient Problem Impaired Healing (2378)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Pt had robotic assisted sleeve gastrectomy possible open procedure on (b)(6) 2019."pt returned to surgery for post-op bleed on the pt in question." on (b)(6) 2019 pt discharged home.Hosp received recall on july 11, 2019 for select lot numbers of green and black sureform 60 staple loads.Pt is readmitted on (b)(6) 2019 with severe abdominal pain.Endoscopy was performed, which revealed a substantial gastric leak.Pt was placed in icu and is improving.

• Brand Name: DA VINCI XI SUREFORM STAPLER RELOAD
• Type of Device: STAPLER LOAD
• Manufacturer (Section D): INITIATIVE SURGICAL ; sunnyvale CA
• MDR Report Key: 8842096
• MDR Text Key: 152832574
• Report Number: 8842096
• Device Sequence Number: 2
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/23/2019,07/11/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48360T-08
• Device Catalogue Number: 48360T-08
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2019
• Distributor Facility Aware Date: 07/11/2019
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 150