BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID FIRE

    MDR report key: 759229 · Received September 9, 2006

    Report

    Report Number
    1223688-2006-00016
    Event Type
    Injury
    Date Received
    September 9, 2006
    Date of Event
    August 1, 2006
    Report Date
    September 8, 2006
    Manufacturer
    CONMED ENDOSCOPIC TECHNOLOGIES
    Product Code
    FHN
    PMA / PMN Number
    K971137
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. THEREFORE, NO INVESTIGATION OR CORRECTIVE ACTION WILL BE INITIATED, AS ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. THE COMPLAINT DATABASE WILL BE MONITORED FOR FURTHER OCCURRENCES. REFER TO MFR REPORT #1223688-2006-00015 FOR INFORMATION REGARDING DEVICE #1.

    Description of Event or Problem · 1

    DEVICE #2. TWO DEVICES WERE USED IN THE PROCEDURE ON ONE PATIENT. USING THE SECOND DEVICE IN THE KIT, THE DOCTOR ACHIEVED RED OUT, BUT THE BANDS FELL OFF THE GRADE 3 VARIX AND FAILED TO CAPTURE. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL TO COMPLETE PROCEDURE. THERE WAS NO PATIENT HARM. REFER TO MFR REPORT #1223688-2006-00015 FOR INFORMATION REGARDING DEVICE #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID FIRE LIGATOR FHN CONMED ENDOSCOPIC TECHNOLOGIES NA ETQEH001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization