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Adverse Event Report

ETHICON-ENDOSURGERY, INC. ENDOPATH EMS ENDOSCOPIC MULTIFEED STAPLER   back to search results
Catalog Number FDH37
Event Date 03/28/1997
Patient Outcome  Other; Required Intervention
Event Description

When testing hernia tray stapler before using it, discovered it didn't work.

 
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Brand NameENDOPATH EMS
Type of DeviceENDOSCOPIC MULTIFEED STAPLER
Baseline Brand NameENDOPATH ENDOSCOPIC MULTIFEED STAPLER
Baseline Generic NameOTHER STAPLERS & ACCESSORIES
Baseline Catalogue NumberEMS
Baseline Model NumberEMS
Baseline Device FamilyOTHER STAPLERS & ACCESSORIES
Baseline Device 510(K) NumberK760733
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed03/31/1994
Manufacturer (Section F)
ETHICON-ENDOSURGERY, INC.
ave. de las torres 7125
col. salvarcar 118
cuidad, juarez chihua
MEXICO
Manufacturer (Section D)
ETHICON, INC.
somerville NJ 08876 0151
Device Event Key104299
MDR Report Key106071
Event Key99721
Report Number106071
Device Sequence Number1
Product CodeGAG
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/17/1997,04/01/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/01/1998
Device Catalogue NumberFDH37
Device LOT NumberK45X97
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/28/1997
Device Ageunknown
Event Location Hospital
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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