BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENLITE DISP MTL MAC 4

    MDR report key: 9078352 · Received September 17, 2019

    Report

    Report Number
    8030121-2019-00076
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 26, 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). THE SAMPLE WAS RETURNED AND SENT TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTS THE FOLLOWING: "DHR DATA REVIEWED FOR LOT 1810341 AND NO ISSUE REPORTED DURING INSPECTION FOR ANY LIGHT FAILURE OR FUNCTIONALITY ISSUES REPORTED. SAMPLE RECEIVED IN BROKEN STAGE BUT WHEN WE TESTED THAT ON RUSCH GREENLED HANDLE, WE FOUND PERFECT TRANSMISSION OF LIGHT FROM LIGHT GUIDE SOURCE ON BLADE. SAME PRODUCT WAS TESTED ON TRUPHATEK GREEN SPECS HANDLE AND RESULT WAS SAME AS PER PREVIOUS TESTING. IN BOTH CASES, WE FOUND BLADE WAS PERFORMING WELL EVEN THOUGH IT WAS RECEIVED BROKEN. COMPLAINT SAMPLE IS QUALIFYING THE LIGHT TESTING. THERE WERE NOT ISSUE WITH THE BLADE FOUND. THERE MIGHT BE AN ISSUE INTO THE POWER SOURCE MECHANISM OF HANDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "INCIDENT FROM THE ER DEPARTMENT REGARDING A LARYNGOSCOPIC BLADE REFERENCE 004551004, LOT 1810341, BRAND RUSCH. THE BLADE DID NOT TRIGGER THE LARYNGOSCOPIC LIGHT.". THE ISSUE OCCURED PRIOR TO INTUBATION AND A NEW BLADE WAS USED. NO PATIENT INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BLADE WAS NOT TESTED PRIOR TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "INCIDENT FROM THE ER DEPARTMENT REGARDING A LARYNGOSCOPIC BLADE REFERENCE 004551004, LOT 1810341, BRAND RUSCH. THE BLADE DID NOT TRIGGER THE LARYNGOSCOPIC LIGHT.". THE ISSUE OCCURED PRIOR TO INTUBATION AND A NEW BLADE WAS USED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871873 RUSCH GREENLITE DISP MTL MAC 4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 1810341

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.