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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN/MEDTRONIC EGIAVSHORT STAPLER

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COVIDIEN/MEDTRONIC EGIAVSHORT STAPLER Back to Search Results
Model Number EGIAVSHORT
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2017
Event Type  Malfunction  
Event Description

The surgeon was using the covidien 45 mm purple load for a wedge resection on the patient's left lung and the device failed to complete the cut. A new handle and a new load were opened, the rep called and informed as well. The rep suggested a 45 mm black load for a thicker tissue to be used next. It was unclear if the issue was the load or the handle.

 
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Brand NameEGIAVSHORT
Type of DeviceSTAPLER
Manufacturer (Section D)
COVIDIEN/MEDTRONIC
710 medtronic pkwy.
minneapolis MN 55432 5604
MDR Report Key6423891
MDR Text Key70644558
Report NumberMW5068565
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/17/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received03/17/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2021
Device MODEL NumberEGIAVSHORT
Device Catalogue NumberN6J0350KX
Device LOT NumberP6E0208X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
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? No
Type of Device Usage

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