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Adverse Event Report

ETHICON ENDO-SURGERY, INC. (JUAREZ) LIGACLIP ERCA ENDOSCOPIC MULTIPLE CLIP APPLIER CLIP APPLIERS - ENDOSCOPIC   back to search results
Catalog Number ER320
Event Date 02/18/2002
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Eval summary: the analysis results confirmed that the er320 instrument was nonfunctional. The instrument was found to have an insufficient crimp and therefore had a nonconforming feed.

 
Event Description

It was reported that the clips did not form correctly. The case was completed with another device. There was no consequence to the patient.

 
Manufacturer Narrative

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

 
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Brand NameLIGACLIP ERCA ENDOSCOPIC MULTIPLE CLIP APPLIER
Type of DeviceCLIP APPLIERS - ENDOSCOPIC
Baseline Brand NameLIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER
Baseline Generic NameENDOSCOPIC CLIP APPLIER
Baseline Catalogue NumberER320
Other Baseline ID NumberBATCH #:J44J8R
Baseline Device 510(K) Number
Baseline Device PMA Number
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 Key375951
MDR Report Key386924
Event Key365356
Report Number1527736-2002-00533
Device Sequence Number1
Product CodeGDO
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/18/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberER320
Device LOT NumberP4NT5E
OTHER Device ID NumberP53M01
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 Received02/18/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2001
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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