BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENLITE DISP MTL MAC 4

    MDR report key: 9141534 · Received October 1, 2019

    Report

    Report Number
    8030121-2019-00086
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 9, 2019
    Report Date
    September 9, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: LOT # CORRECTED TO 1812341. THE SAMPLE WAS RECEIVED AND RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE MANUFACTURING SITE REPORTS THAT DURING INSPECTION IT WAS OBSERVED THAT BLADE'S ONE WELDING JOINT WAS BROKEN. SINCE THE BLADE WAS FOUND DISMANTLED DURING ENGAGING ON THE HANDLE IT WAS DETERMINED IT IS A MANUFACTURING ISSUE. THE MANUFACTURER ALSO REPORTS THAT THE DEVICE IS INSPECTED PRIOR TO RELEASE THUS IT IS CONFIRMED THAT IT LEFT THE MANUFACTURING FACILITY FULLY FUNCTIONAL. STRENGTH OF SPOT-WELDED JOINTS CANNOT BE TESTED FOR 100% WHICH COULD LEAD TO THE POSSIBILITY OF SHIPPING PRODUCT WITH WEAK SPOT-WELDING JOINT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. THE BLADE WAS BROKEN INTO TWO PARTS FROM THE WELDED JOINTS. THIS IS A MANUFACTURING RELATED ISSUE. A NON-CONFORMANCE WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT DURING THE INDUCTION PHASE OF INTUBATION "THE GREEN PART OF THE BLADE BROKE WHILST SNAPPING IT TO THE LARYNGOSCOPE'S HANDLE.". THERE WAS NO PATIENT INJURY, BUT A DELAY IN THE INTUBATION PROCEDURE WAS REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING THE INDUCTION PHASE OF INTUBATION "THE GREEN PART OF THE BLADE BROKE WHILST SNAPPING IT TO THE LARYNGOSCOPE'S HANDLE.". THERE WAS NO PATIENT INJURY, BUT A DELAY IN THE INTUBATION PROCEDURE WAS REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936527 RUSCH GREENLITE DISP MTL MAC 4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 1812341

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED| NONE REPORTED