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Adverse Event Report

ETHICON ENDO-SURGERY, INC. (JUAREZ) LIGACLIP LIGACLIP ERCA ENDOSCOPIC MULTIPLE CLIP APPLIE CLIP APPLIERS-ENDOSCOPIC   back to search results
Catalog Number ER320
Event Date 10/22/2001
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Eval summary: the analysis results confirmed that the jaws of the er320 instrument had become damaged and could not hold the clips properly, making the instrument non-functional.

 
Event Description

It was reported that the device was to be used during a general surgical procedure. It was reported that device does not staple. There was no consequence to the pt.

 
Manufacturer Narrative

H6: yielded jaws. Evaluation summary: the analysis results confirmed that the jaws of the er320 instrument had become damaged and could not hold the clips properly, making the instrument nonfunctional. No conclusion could be reached based on the analysis results as to what may have caused the damage.

 
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Brand NameLIGACLIP LIGACLIP ERCA ENDOSCOPIC MULTIPLE CLIP APPLIE
Type of DeviceCLIP APPLIERS-ENDOSCOPIC
Baseline Brand NameLIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
Baseline Generic NameIMPLANTABLE CLIPS
Baseline Catalogue NumberER320
Baseline Model NumberER320
Baseline Device FamilyENDOSCOPIC SINGLE STAINLESS CLIPS
Baseline Device 510(K) NumberK830503
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed01/25/1994
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC. (JUAREZ)
avenida de las torres 7125
parque indust. salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC. (JUAREZ)
avenida de las torres 7125
parque indust. salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer Contact
tom bosticco manager
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key373166
MDR Report Key384119
Event Key362647
Report Number1527736-2002-00514
Device Sequence Number1
Product CodeGDO
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/20/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date05/22/2006
Device Catalogue NumberER320
Device LOT NumberP4MY2Z
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/11/2002
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received12/20/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2001
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 February 28, 2009

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