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Adverse Event Report

ETHICON ENDO-SURGERY, INC. PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT LINEAR CUTTERS - CONVENTIONAL   back to search results
Catalog Number TLC10
Event Date 11/04/2003
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

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

 
Event Description

When the device was used during a pancreatic procedure, it fired malformed staples. The case was completed using sutures. There was no patient consequence.

 
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Brand NamePROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT
Type of DeviceLINEAR CUTTERS - CONVENTIONAL
Baseline Brand NameLINEAR CUTTER W/SAFETY LOCK-OUT 100MM
Baseline Generic NameLINEAR CUTTER
Baseline Catalogue NumberTLC10
Baseline Device FamilyLINEAR CUTTERS - CONVENTIONAL
Baseline Device 510(K) NumberK843034
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed09/17/1984
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati OH 45242 2803
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC.
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
tom bosticco
4545 creek rd
cincinnati , OH 45242-2803
(513) 337 -8935
Device Event Key489318
MDR Report Key500550
Event Key474674
Report Number1527736-2003-02448
Device Sequence Number1
Product CodeGCJ
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 11/05/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberTLC10
Device LOT NumberT4WX6M
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 Received11/05/2003
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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