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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 05/09/2002
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that during a laparoscopic cholecystectomy the instrument seemed to fire normally but one of the clips did not form completely. The case was completed with a same like device. There was no pt consequence.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Eval summary: the er320 instrument was returned in good visual condition. The instrument was cycled, fed, and formed the remaining clips within mfg requirements when tested. The instrument was fully functional and conforming to mfg requirements.

 
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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 rd
cincinnati , OH 45242
(513) 337 -8935
Device Event Key389941
MDR Report Key400891
Event Key378856
Report Number1527736-2002-01184
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 05/09/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberER320
OTHER Device ID NumberR90537
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received05/09/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2002
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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