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Adverse Event Report

ETHICON ENDO-SURGERY, INC. (CINCINNATI) ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5MM   back to search results
Catalog Number TSB45
Event Type  Malfunction  
Event Description

It was reported that during an endoscopic sigma procedure, the staples would not close but the instrument cut. 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 ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5MM
Type of DeviceENDOSCOPIC LINEAR CUTTER
Baseline Brand NameETS
Baseline Generic NameLINEAR CUTTER
Baseline Catalogue NumberTSB45
Baseline Device FamilyLINEAR CUTTERS - ENDOSCOPIC
Baseline Device 510(K) NumberK915099
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed09/19/1992
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 Key516734
MDR Report Key527565
Event Key500796
Report Number1527736-2004-00461
Device Sequence Number1
Product CodeKOG
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 02/03/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberTSB45
Device LOT NumberT4XH07
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Not Applicable
Date Manufacturer Received02/03/2004
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 January 30, 2009

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