MAUDE Adverse Event Report: COVIDIEN LLC EGIA 4 HANDLE STANDARD; STAPLER, SURGICAL

Model Number EGIA 1418524

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 04/11/2019

Event Type  Death  

Event Description

The pt was a male with bladder and prostate cancer who underwent a left nephrectomy on (b)(6) 2019, due to poorly function hydronephrotic left kidney with in ability to tolerate nephrostomy tubes.During surgery, a vascular stapler was placed across the renal vein and artery en bloc and was fired.Approx a few seconds after, there was significant blood in the retroperitoneum.Rescue attempts were unsuccessful, and the pt expired.Fda safety report id# (b)(4).

• Brand Name: EGIA 4 HANDLE STANDARD
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN LLC
• MDR Report Key: 8564878
• MDR Text Key: 143598706
• Report Number: MW5086251
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EGIA 1418524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death