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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ETHICON STAPLER

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ETHICON ETHICON STAPLER Back to Search Results
Model Number PSE45A
Device Problem Misfire (2532)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2016
Event Type  Malfunction  
Event Description

Stapler misfired.

 
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Brand NameETHICON STAPLER
Type of DeviceSTAPLER
Manufacturer (Section D)
ETHICON
somerville NJ 08876
MDR Report Key6017010
MDR Text Key57162784
Report NumberMW5065278
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 10/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2019
Device MODEL NumberPSE45A
Device LOT NumberN92C9T
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? 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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