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Adverse Event Report

ETHICON ENDO-SURGERY, INC.(TORRES) ENDOPATH ETS FLEX 45MM LINEAR CUTTERS - ETS45MM   back to search results
Catalog Number ATB45
Event Date 06/17/2002
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Eval summary: no conclusion could be reached. The analysis results found that the instrument was returned in good visual condition with a fully fired cartridge. The instrument did not pass the cannula gage test due to a damaged closure ring. The damaged to the closure ring is consistent with damaged observed when the instrument is clamped on tissue that is thicker than indicated. All instruments are fired and passed through cannula gage test 100% in process to verify proper functionality. The instrument was tested for functionality with a test cartridge and fired, cut, and formed the staples within mfg requirements. The staples were noted to hav a proper b-formation.

 
Event Description

It was reported that during a laparoscopic pancreatic pseudocyst, the staples reportedly did not form completely. The case was completed by hand suture with 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 FLEX 45MM
Type of DeviceLINEAR CUTTERS - ETS45MM
Baseline Brand NameARTICULATING LINEAR CUTTER
Baseline Generic NameLINEAR CUTTER
Baseline Catalogue NumberATB45
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.(TORRES)
avenida de las torres 7125
parque indust salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC.(TORRES)
avenida de las torres 7125
parque indust salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer Contact
tom bosticco, mgr
4545 creek rd
cincinnati , OH 45242
(513) 337 -8935
Device Event Key394961
MDR Report Key405972
Event Key383714
Report Number1527736-2002-01473
Device Sequence Number1
Product CodeGCJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/17/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberATB45
Device LOT NumberR4RR31
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received06/17/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2001
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 January 30, 2009

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