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Adverse Event Report

COOK, INCORPORATED CAREY-ALZATE-COONS GASTROJEJUNOSTOMY SET SPECIAL SET   back to search results
Catalog Number GJS-1020
Device Problem Migration
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

In three instances, the malecot of the catheter migrated out of the stomach and the patient developed peritonitis.

 
Manufacturer Narrative

Neither the product nor the lot number was provided to assist in this investigation. However, the complaint information states that the physician, following placement of the catheter, is cutting the suture anchor retention string. This does not allow the tract to develop. Wihtout a chance to develop, it is possible that the catheter may migrate, resulting in the difficulty encountered. A review of the ifu t-gjs602, revealed that the suture may be cut after catheter placement. Therefore, corrective action has been submitted as a result of this complaint in an effort to clarify this statement.

 
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Brand NameCAREY-ALZATE-COONS GASTROJEJUNOSTOMY SET
Type of DeviceSPECIAL SET
Baseline Brand NameCAREY-ALZATE-COONS GASTROJEJUNOSTOMY SET
Baseline Generic NameNA
Baseline Catalogue NumberGJS-1020
Baseline Device FamilySPECIAL SET
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Manufacturer (Section F)
COOK, INCORPORATED
750 daniels way
bloomington IN 47404 0489
Manufacturer (Section D)
COOK, INCORPORATED
750 daniels way
bloomington IN 47404 0489
Manufacturer Contact
rita harden
750 daniels way
bloomington , IN 47404
(812) 339 -2235
Device Event Key454948
MDR Report Key466002
Event Key441622
Report Number1820334-2003-00070
Device Sequence Number1
Product CodeEZD
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/23/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberGJS-1020
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received05/23/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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