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, INC. (CINCINNATI) ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM ENDO LINEAR CUTTERS - ETS45MM   back to search results
Catalog Number TSW45
Event Date 04/14/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

During a hand assisted lap nephrectomy, the stapler did not fire all the way. It cut part and did not lay staples on one half of the cartridge. They were going across the renal vessel. The pt started uncontrolled bleeding and they had to open the pt up. It is unknown if the pt received a transfusion.

 
Manufacturer Narrative

D4; h4, 6: information anticipated, but unavailable at this time.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM
Type of DeviceENDO LINEAR CUTTERS - ETS45MM
Baseline Brand NameETS ENDOSCOPIC LINEAR CUTTER
Baseline Generic NameLINEAR CUTTER
Baseline Catalogue NumberTSW45
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)
cincinnati OH *
Manufacturer (Section D)
ETHICON ENDO SURGERY, INC. (CINCINNATI)
cincinnati OH *
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 45242-3803
(513) 337 -8582
Device Event Key513728
MDR Report Key524600
Event Key497915
Report Number1527736-2004-01339
Device Sequence Number1
Product CodeKOG
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 04/15/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberTSW45
Device LOT NumberV4ZK22
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 Received04/15/2004
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 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