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Adverse Event Report

ETHICON ENDO-SURGERY, INC. (TORRES) PROXIMATE TX RELOADALBE LINEAR STAPLER LINEAR STAPLERS   back to search results
Catalog Number TX60G
Event Date 09/11/2002
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported when the device was used during a gastric bypass, the anvil pin extended past the anvil hole. The case was completed with no pt consequence.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Eval summary: two instruments (a-b) arrived in good visual condition. They were fired with a test cartridge, and they fired and formed all the staples within mfg requirements. However, the retaining pin extended poast the anvil hook on both instruments. Ees has implemented actions that should help reduce the liklihood of reoccurence of this event.

 
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Brand NamePROXIMATE TX RELOADALBE LINEAR STAPLER
Type of DeviceLINEAR STAPLERS
Baseline Brand NamePROXIMATE RELOADABLE LINEAR STAPLER
Baseline Generic NameSTAPLE, IMPLANTABLE
Baseline Catalogue NumberTX60G
Baseline Model NumberTX60G
Baseline Device FamilyLINEAR STAPLERS
Baseline Device 510(K) NumberK890841
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed08/03/1982
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC. (TORRES)
avenida de las torres 7125
parque indust. salvarcar 118
ciudad juarez chihuahua
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC. (TORRES)
avenida de las torres 7125
parque indust. salvarcar 118
ciudad juarez chihuahua
Manufacturer Contact
tom bosticco manager
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key410362
MDR Report Key421331
Event Key398476
Report Number1527736-2002-02039
Device Sequence Number1
Product CodeGAG
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/11/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/03/2007
Device Catalogue NumberTX60G
Device LOT NumberR4RP8E
OTHER Device ID NumberR54T82
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2002
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received09/11/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2002
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Database last updated on February 28, 2009

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