BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAG 4X6 10M 225ML VOL, MONARCH RETRIEVAL BAG

    MDR report key: 1015099 · Received March 19, 2008

    Report

    Report Number
    2027111-2008-00007
    Event Type
    Other
    Date Received
    March 19, 2008
    Date of Event
    January 28, 2008
    Report Date
    March 19, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: PRODUCT WAS NOT RETURNED FOR EVALUATION, WHICH MAKES PROPER ASSESSMENT OF THE FAILURE DIFFICULT TO DETERMINE. TYPICAL FAILURE OF THE PRODUCT IS NOT A RESULT OF SEAM SEPARATION/BREAKS, BUT FROM STRETCHING AND BREAKAGE OF THE TISSUE BAG MATERIAL. MOST BREAKS IN THE MATERIAL OCCUR NEAR THE BOTTOM SEAM OF THE BAG DUE TO EXCESSIVE FORCE ON THE TISSUE BAG WHEN SPECIMEN IS BEING REMOVED FROM THE PORT SITE. SEAM STRENGTH TESTS OF TISSUE BAGS USED FOR THE TOP LEVEL TISSUE RETRIEVAL SYSTEM, LOT 1030849, WERE PERFORMED ON THE TISSUE BAG SUB-ASSEMBLY SHOP ORDERS. ALL BAG PULL TESTING CONDUCTED ON THE TWO LOTS PASSED MINIMUM REQUIREMENT OF 5 LBS. CONCLUSION/CORRECTIVE ACTION: FROM THE LIMITED/INSUFFICIENT INFO PROVIDED BY THE CUSTOMER AND FAILURE TO RETURN THE PRODUCT FOR EVALUATION, IT CANNOT BE DETERMINED AT THIS TIME IF THE FAILURE OCCURRED DUE TO SEPARATION OF THE SEAM OR A BREAK OF THE TISSUE BAG MATERIAL. STRETCHING AND BREAKS IN THE TISSUE BAG MATERIAL USUALLY INDICATE THAT PID INSTRUCTIONS WERE NOT PROPERLY FOLLOWED. INSTRUCTIONS INCLUDED WITH THE PRODUCT STATE, "NOTE: IF THE BAG AND ITS CONTENTS ARE TOO LARGE TO BE EXTRACTED, CAREFULLY ENLARGE THE PORT SITE FOR EASE OF BAG REMOVAL." FOR PROPER ASSESSMENT OF FAILURE, PRODUCT SHOULD BE RETURNED AND DETAILED DESCRIPTION OF THE PRODUCT AND EVENT SHOULD BE NOTED IN THE CUSTOMER EXPERIENCE REPORT. MEANS FOR IMPROVING THE STRENGTH OF THE PRODUCT ARE BEING INVESTIGATED. NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    "BAG BROKE AS SURGEON WAS REMOVING THROUGH THE BAG SITE. BAG WOULD NOT DEPLOY THROUGH THE TROCAR." PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAG 4X6 10M 225ML VOL, MONARCH RETRIEVAL BAG MONARCH RETRIEVAL BAG GCJ APPLIED MEDICAL RESOURCES CD001 1030849

    Patients

    Seq Age Sex Outcome Treatment
    1 Other