BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 1070575 · Received July 2, 2008

    Report

    Report Number
    3005075853-2008-00268
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THE BULLED SPRING WAS DAMAGED, THEREFORE, IT WOULD NOT ALLOW THE PUSH PULL ROD TO RETRACT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, ONCE THE DEVICE WAS OPEN INSIDE THE PT, IT WOULD NOT CLOSE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVER SPEC BAG GCJ ETHICON ENDO-SURGERY, LLC NA E4KH63

    Patients

    Seq Age Sex Outcome Treatment
    1