BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004659744-2006-00005

    MDR report key: 892165 · Received January 30, 2007

    Report

    Report Number
    3004659744-2006-00005
    Event Type
    Malfunction
    Date Received
    January 30, 2007
    Product Code
    KPR
    PMA / PMN Number
    K042438
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INITIAL INVESTIGATION SEVERAL FLAKES AND GROOVES WERE OBSERVED ON THE INNER DIAMETER (ID) OF THE RETURNED EWC. NO LOOSE PARTICLES WERE SEEN. THIS CONDITION WAS DUPLICATED ON A NEW EWC PULLED FROM STOCK AFTER "VIGOROUS SCRAPING" WITH AN ENDOSCOPE TOOL. ENDOSCOPE TOOLS SUCH AS FORCEPS ARE DESIGNED TO HAVE SHARP EDGES AND THE DAMAGE SEEN DURING THE PROCEDURE IS CONSISTENT WITH EXCESSIVE FORCE BY THE USER. TO MITIGATE THE RISKS THE SDBS UNDER MANUAL INCLUDES THE FOLLOWING WARNING. "NEVER USE EXCESSIVE FORCE (1 KG FORCE (10N) DURING THE INSERTION OR EXTRACTION OF THE LOCATABLE GUIDE OR ENDOSCOPIC TOOLS THROUGH THE EWC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KPR

    Patients

    Seq Age Sex Outcome Treatment
    1