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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ETHICON ECHELON FLEX POWERED PLUS STAPLER

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ETHICON ETHICON ECHELON FLEX POWERED PLUS STAPLER Back to Search Results
Model Number PLEE60A
Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 10/12/2017
Event Type  Malfunction  
Event Description

Stapler malfunction. Stapler initiated and it stopped prior to blade being recessed back into gun.

 
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Brand NameETHICON ECHELON FLEX POWERED PLUS STAPLER
Type of DeviceSTAPLER
Manufacturer (Section D)
ETHICON
somerville NJ 08876
MDR Report Key6954243
MDR Text Key89694243
Report NumberMW5072771
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/17/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device MODEL NumberPLEE60A
Device LOT NumberP93C19
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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