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Adverse Event Report

ETHICON ENDO-SURGERY, INC.(CINCINNATI) ENDOPATH ETS ARTICULATING ENDOSCOPIC LINEAR CUTTER LONG ENDO LINEAR CUTTERS - ETS45MM   back to search results
Catalog Number LONG45A
Event Date 02/11/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported when the device was used during a laparoscopic roux-en-y, it would not open after it was fired. The case was completed using another device. There was no pt consequence.

 
Manufacturer Narrative

D5, 6; h4, 6: info anticipated, but unavailable at this time.

 
Search Alerts/Recalls

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Brand NameENDOPATH ETS ARTICULATING ENDOSCOPIC LINEAR CUTTER LONG
Type of DeviceENDO LINEAR CUTTERS - ETS45MM
Baseline Brand NameENDOPATH ETS FLEX 45MM
Baseline Generic NameLAPARASCOPE GENERAL & PLASTIC SURGERY
Baseline Catalogue NumberLONG45A
Baseline Device FamilyLINEAR CUTTERS - ETS45MM
Baseline Device 510(K) NumberK002398
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed05/12/1998
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC.(CINCINNATI)
4545 creek rd.
cincinnati OH 45242 2803
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC.(CINCINNATI)
4545 creek rd.
cincinnati OH 45242 2803
Manufacturer (Section G)
ETHICON ENDO SURGERY, INC. (TORRES)
avenida de las torres
7125 parque
ciudad juarez chihuahua
MEXICO
Manufacturer Contact
gary leblanc
4545 creek rd
cincinnati , OH 45242-2803
(513) 337 -8582
Device Event Key521255
MDR Report Key532007
Event Key505082
Report Number1527736-2004-00601
Device Sequence Number1
Product CodeKOG
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 02/16/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLONG45A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Not Applicable
Date Manufacturer Received02/16/2004
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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