BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL PHARYNGEAL II DEL. KIT

    MDR report key: 59580 · Received December 24, 1996

    Report

    Report Number
    2914019-1996-00013
    Event Type
    Malfunction
    Date Received
    December 24, 1996
    Date of Event
    November 13, 1996
    Report Date
    December 19, 1996
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6-INVESTIGATION AT USER FACILITY HAS SHOWN THAT THE DEVICE WAS TAMPERED WITH PRIOR TO EVENT. THE SPATULA WAS BENT AND THEREFORE LOOSE AT THE TIME IT WAS USED. H6-PREVIOUS CODE UNDER RESULTS AS 999 IS INCORRECT.

    Description of Event or Problem · 1

    PT INGESTED SPATULA TIP FROM HANDPIECE. THE TIP BECAME DISLODGED DURING SURGERY WHEN THE PT MOVED THEIR HEAD UNEXPECTEDLY. THE PT WAS RELOCATED TO A HOSPITAL TO HAVE THE TIP REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL PHARYNGEAL II DEL. KIT CO2 DELIVERY DEVICE GEX COHERENT MEDICAL LASER GROUP * K951812

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention