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Adverse Event Report

ETHICON ENDO-SURGERY, INC./S.A. DE C.V. ENDOPATH ENDOSCOPIC MULTIFEED STAPLER   back to search results
Catalog Number EMS
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that an ems was used during a laparoscopic hernia procedure. It was reported by the affiliate that the staples will not close. There was no consequence to the pt.

 
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Brand NameENDOPATH ENDOSCOPIC MULTIFEED STAPLER
Type of DeviceSTAPLER
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 ENDO-SURGERY, INC./S.A. DE C.V.
ave las torres #7125
col salvarcar 118
juarez
MEXICO
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC./S.A. DE C.V.
ave las torres #7125
col salvarcar 118
juarez
MEXICO
Manufacturer (Section G)
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati OH 45242 2839
Manufacturer Contact
kay jackson
4545 creek rd
cincinnati , OH 45242-2839
(513) 483 -8148
Device Event Key173442
MDR Report Key178377
Event Key167649
Report Number1527736-1998-02150
Device Sequence Number1
Product CodeGAG
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/08/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/10/2003
Device Catalogue NumberEMS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Other
Date Manufacturer Received07/08/1998
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on December 31, 2008

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