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U.S. Department of Health and Human Services

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

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COVIDIEN LLC EGIA 4 HANDLE STANDARD STAPLER, SURGICAL Back to Search Results
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).

 
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Brand NameEGIA 4 HANDLE STANDARD
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
COVIDIEN LLC
MDR Report Key8564878
MDR Text Key143598706
Report NumberMW5086251
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEGIA 1418524
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/29/2019 Patient Sequence Number: 1
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