FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

ETHICON ENDO-SURGERY ENDOPATH ETS-FLEX COMPACT ENDOSCOPIC LINEAR CUTTER   back to search results
Catalog Number SCW45
Event Type  Malfunction  
Event Description

It was reported that the device would not open. The device then would not fire and locked out. There was no patient consequence.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameENDOPATH ETS-FLEX COMPACT ENDOSCOPIC LINEAR CUTTER
Type of DeviceENDOSCOPIC LINEAR CUTTER
Baseline Brand NameARTICULATING LINEAR CUTTER
Baseline Generic NameLINEAR CUTTER
Baseline Catalogue NumberSCW45
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
4545 creek road
cincinnati OH 45242 2803
Manufacturer (Section D)
ETHICON ENDO-SURGERY
4545 creek road
cincinnati OH 45242 2803
Manufacturer Contact
tom bosticco
4545 creek rd
cincinnati , OH 45242-2803
(513) 337 -8935
Device Event Key421883
MDR Report Key432925
Event Key409622
Report Number1527736-2002-02664
Device Sequence Number1
Product CodeGCJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 11/15/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSCW45
Device LOT NumberR4TT5A
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 Received11/15/2002
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH