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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ETHICON POWER STAPLER ECHELON FLEX 45

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ETHICON ETHICON POWER STAPLER ECHELON FLEX 45 Back to Search Results
Model Number PSE45A
Event Date 05/09/2016
Event Type  Injury  
Event Description

Stapler misfired in pt. No injury related to pt.

 
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Brand NameETHICON POWER STAPLER
Type of DeviceECHELON FLEX 45
Manufacturer (Section D)
ETHICON
cincinatti OH 45242
MDR Report Key5675342
Report NumberMW5062449
Device Sequence Number1
Product CodeGDW
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberPSE45A
Device LOT NumberN90M7Y
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
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

Patient TREATMENT DATA
Date Received: 05/19/2016 Patient Sequence Number: 1
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