BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER FIBRELIGHT MCCOY SIZE 3

    MDR report key: 2816858 · Received October 23, 2012

    Report

    Report Number
    9610531-2012-00001
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 23, 2012
    Manufacturer
    PENLON LTD.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMERS PRODUCT WAS RETURNED AND INVESTIGATED. TESTING OF THE RIVET SHOWED THAT THE FAILURE OF THE RIVET WAS NOT DUE TO EXCESSIVE FORCES DURING NORMAL USE. THE RIVET COULD NOT HAVE BROKEN BY APPLYING FORCES TO THE HANDLE, WITH THE TILTING TIP RESTRAINED. THE RIVETS WERE SHEARED OFF DURING TESTING BY APPLYING A FORCE TO THE TILTING TIP WITH THE ACTUATING MECHANISM LOCKED. THE CHARACTERISTICS OF THE FRACTURES OF THE RETURNED AND TESTED PRODUCTS AND INDICATED THAT THE FRACTURE WAS NOT CAUSED BY A SHEAR FORCE. THE FRACTURE WAS COMPARABLE TO FATIGUE TESTING (WHERE THE ROD WAS MOVED FROM SIDE TO SIDE). THIS ISSUE WAS ATTRIBUTED TO PREMATURE COMPONENT FAILURE AS A RESULT OF ABNORMAL TENSILE FORCE BEING APPLIED TO THE PART.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A METAL PIECE FROM THE BLADE BROKE OFF DURING THE INTUBATION PROCEDURE AND LODGED IN THE AIRWAY OF THE PT. MEDICAL INTERVENTION WAS REQUIRED AS AN ENT SURGEON HAD TO BE CALLED TO REMOVE IT FROM THE PT'S AIRWAY. THE BLADE HAD BEEN CHECKED BY TWO NURSES PRIOR TO USE AND NO DAMAGE WAS EVIDENT. ON INITIAL INVESTIGATION OF THE RETURNED PRODUCT THE RIVET HOLDING THE ACTUATING ROD TO THE TILTING TIP HAD BROKEN AND THE RIVET HAD LANDED IN THE PT AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIER FIBRELIGHT MCCOY SIZE 3 RIGID LARYNGOSCOPE CCW PENLON LTD. NA R12

    Patients

    Seq Age Sex Outcome Treatment
    1 Other