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, ALB PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLERS   back to search results
Catalog Number CDH29
Event Date 07/21/2000
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Analysis conclusion: based on the info received and the visual and functional results, no conclusion could be reached as to what may have caused the reported incident. Upon receipt of the instrument, it was verified that the staples were protruding. The staples were reinstated back into the staple housing. A vigorous tap test was performed with no protruding staples noted. The appropriate personnel have been notified of the reported incident.

 
Event Description

It was reported that (1) device was used during an unknown procedure. It was reported by the affiliate that the cdh29 instrument staples protruded. Another instrument was used to complete the case. There was no consequence to the pt.

 
Manufacturer Narrative

Sent 08/23/2000. A1,2,3,4;b6,7;d10;e1: info not provided by affiliate. D5,6;h4,6: info anticipated, but unavailable at this time.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NamePROXIMATE I L S INTRALUMINAL STAPLER
Type of DeviceCIRCULAR STAPLERS
Baseline Brand NamePROXIMATE ILS INTRALUMINAL CIRCULAR STAPLER
Baseline Generic NameCIRCULAR STAPLERS
Baseline Catalogue NumberCDH29
Baseline Device FamilyPROXIMATE ILS CIRCULAR STAPLERS
Baseline Device 510(K) NumberK940967
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed06/20/1980
Manufacturer (Section F)
ETHICON ENDO-SURGERY, ALB
3801 university blvd., se
albuquerque NM 87125 6202
Manufacturer (Section D)
ETHICON ENDO-SURGERY, ALB
3801 university blvd., se
albuquerque NM 87125 6202
Manufacturer Contact
john huff manager
4545 creek road
cincinnati , OH 45242
(513) 337 -7460
Device Event Key282883
MDR Report Key292268
Event Key274400
Report Number1527736-2000-03967
Device Sequence Number1
Product CodeGAG
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/27/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/01/2005
Device Catalogue NumberCDH29
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received07/27/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/1999
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 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