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Adverse Event Report

ETHICON ENDO-SURGERY, INC. (JUAREZ) LIGACLIP ERCA ENDOSCOPIC MULTIPLE CLIP APPLIER CLIP APPLIER - ENDOSCOPIC   back to search results
Catalog Number ER220
Event Date 03/08/2002
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

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

 
Event Description

It was reported by the affiliate that during an unknown procedure the device producted malformed clips. The case was completed with a same like device. There was no consequence to the patient.

 
Manufacturer Narrative

Eval summary: the analysis results confirmed that the er220 instrument was nonfunctional. The instrument was cycled and ejected the remaining clips unformed due to broken handle posts.

 
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Brand NameLIGACLIP ERCA ENDOSCOPIC MULTIPLE CLIP APPLIER
Type of DeviceCLIP APPLIER - ENDOSCOPIC
Baseline Brand NameLIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
Baseline Generic NameENDOSCOPIC CLIP APPLIER
Baseline Catalogue NumberER220
Other Baseline ID NumberBATCH #.K46G8E
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 bosticoo manager
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key386427
MDR Report Key397374
Event Key375482
Report Number1527736-2002-01021
Device Sequence Number1
Product CodeGDO
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Invalid Data
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/25/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberER220
Device LOT NumberP4NW2N
OTHER Device ID NumberP53R31
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received04/25/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2001
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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