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Adverse Event Report

EES-JUAREZ ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER   back to search results
Catalog Number EMS
Event Date 02/03/1997
Event Type  Malfunction   Patient Outcome  Other;
Event Description

During an open hernia repair the surgeon fired the ems five or six times without a problem. The stapler jammed after the sixth firing and would not feed any more staples. The device was not dry fired. A second device was opened to complete the ase. There was no consequence to the pt.

 
Manufacturer Narrative

H6; broken cartridge nose weld, bent ejector leg and excessive u. V. Adhesive on ejector post. Results of evaluation: conclusion: based upon the inquiry info received and the visual examination, it was concluded that the reported instr. "jammed" may have been due to a bent ejector leg. The instr. Was received with a twisted staple protruding from the cartridge nose, with a broken cartridge nose weld, and with a bent ejector leg. No functional testing could be performed due to the instr. Physical condition. The cartridge was disassembled and was observed to contain a total of 9 staples twisted in the nose. The ejector post was observed to have excessive u. V. (ultra violet) adhesive on top of it. It was concluded that the bent ejector leg may have caused the twisting of the staples and the subsequent breakage of the cartridge nose weld when re-fired. The excessive u. V. Adhesive on the ejector post was due to an assembly error. No conclusion could be reached as to how the ejector leg may have become bent. Comments: the assembly management has been notified of this incident and product inquiry will monitor for add'l occurrences.

 
Search Alerts/Recalls

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Brand NameENDOPATH ENDOSCOPIC MULTIFEED STAPLER
Type of DeviceENDOSCOPIC STAPLER
Baseline Brand NameENDOPATH ENDOSCOPIC MULTIFEED STAPLER
Baseline Generic NameOTHER STAPLERS & ACCESSORIES
Baseline Catalogue NumberEMS
Baseline Model NumberEMS
Baseline Device FamilyOTHER STAPLERS & ACCESSORIES
Baseline Device 510(K) NumberK760733
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed03/31/1994
Manufacturer (Section F)
EES-JUAREZ
sandoval e. ave. rio bravo
d.b. ciudad,juarez,chihuahua
MEXICO
Manufacturer (Section D)
EES-JUAREZ
sandoval e. ave. rio bravo
d.b. ciudad,juarez,chihuahua
MEXICO
Manufacturer (Section G)
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati OH 45242 2839
Manufacturer Contact
kay jackson
4545 creek rd
cincinnati , OH 45242-2839
(513) 483 -8148
Device Event Key82297
MDR Report Key82926
Event Key78043
Report Number1527736-1997-00243
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 03/11/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date09/01/2001
Device Catalogue NumberEMS
Device LOT NumberJ4502F
OTHER Device ID NumberBATCH #:J5043H
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received02/10/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/1996
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 06, 2009

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