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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ECHELON FLEX45 LINEAR CUTTER STAPLER, SURGICAL

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ETHICON ENDO-SURGERY, LLC ECHELON FLEX45 LINEAR CUTTER STAPLER, SURGICAL Back to Search Results
Catalog Number EC45A
Device Problem Difficult to Open or Close (2921)
Patient Problem Insufficient Information (4580)
Event Date 11/05/2020
Event Type  Malfunction  
Event Description

Echelon flex stapler fired in patient, cut and stapled appropriately; however, would not open to fit back through trocar. Fda safety report id# (b)(4).

 
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Brand NameECHELON FLEX45 LINEAR CUTTER
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
MDR Report Key10836383
MDR Text Key216332350
Report NumberMW5097822
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 RISK MANAGER
Type of Report Initial
Report Date 11/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/12/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberEC45A
Device LOT NumberU95D1Z
Was Device Available For Evaluation? Yes
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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