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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON US, LLC ECHELON 60 LONG STAPLER

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ETHICON US, LLC ECHELON 60 LONG STAPLER Back to Search Results
Model Number LONG 60A
Device Problem Misfire (2532)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2016
Event Type  Malfunction  
Event Description

Echelon 60 while used to staple spleen during laparoscopic splenectomy. Md states that stapler misfired.

 
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Brand NameECHELON 60 LONG STAPLER
Type of DeviceECHELON 60 LONG STAPLER
Manufacturer (Section D)
ETHICON US, LLC
4545 creek road
cincinnati OH 45242 2839
MDR Report Key6221741
MDR Text Key63952683
Report NumberMW5067030
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 12/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberLONG 60A
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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