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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 04/10/2002
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Eval summary: the analysis results confirmed that the jaws had become damaged and could not hold a clip properly, making the instrument non-functional. A batch record review was performed and the batch met all finished goods quality assurance requirements.

 
Event Description

It was reported during cholecystectomy the clips did not close during firing. Consequently the clips were malformed. The case was completed with a same like device. There was no patient consequence.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

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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 (Section G)
ETHICON ENDO-SURGERY, INC. (JUAREZ)
avenida de las torres 7125
parque industrial salvarca 118
ciudad juarez chihuahua
MEXICO
Manufacturer Contact
tom bosticco manager
4545 creek rd
cincinnati , OH 45242
(513) 337 -8935
Device Event Key391044
MDR Report Key402018
Event Key379927
Report Number1527736-2002-01214
Device Sequence Number1
Product CodeGDO
Report Source Manufacturer
Source Type Company Representative,Foreign
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/23/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberER320
Device LOT NumberP4M11E
OTHER Device ID NumberN52AK
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 Received05/23/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2000
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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