BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL GENERAL PURPOSE PROBE 12FR

    MDR report key: 5599223 · Received April 22, 2016

    Report

    Report Number
    9613793-2016-00002
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    April 16, 2016
    Report Date
    April 22, 2016
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
    Product Code
    FLL
    PMA / PMN Number
    K925791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: BASED ON INFORMATION RECEIVED FROM THE REPORTING CUSTOMER, THE ROOT CAUSE HAS BEEN IDENTIFIED AS IMPROPER USE OF THE DEVICE. CORRECTIVE ACTION: THE RISK ANALYSIS WILL BE REVIEWED TO ENSURE THE FAILURE MODE AND EFFECT TO THE PATIENT ARE REPRESENTED. THE INSTRUCTIONS FOR USE WILL ALSO BE REVISED FOR CLARITY TO ENSURE SAFE AND EFFECTIVE USE. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED REPORTING THAT A GENERAL PURPOSE PROBE (PART NUMBER 81-020412) WAS USED ON A PATIENT DURING AN MRI PROCEDURE. AFTER WHICH, THE PATIENT RECEIVED A THIRD-DEGREE BURN NEAR THE ARMPIT. A LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS UNAVAILABLE FOR EVALUATION. IN AN EMAIL COMMUNICATION RECEIVED 4/21/2016, THE REPORTING CUSTOMER STATED THE PROBE CONNECTOR END WAS PLACED UNDER THE PATIENT'S RIGHT ARM PIT AND THE TIP OF THE PROBE "WRAPPED UP" AROUND THE NECK "TO THE LEFT SIDE OF THE HEAD IN THE OCCIPITAL AREA." THE INSTRUCTIONS FOR USE (PART 74-14906, REVISION 6/10) PACKAGED WITH PART NUMBER 81-020412 STATE THAT THE PROBE IS INTENDED TO BE USED FOR "ROUTINE MONITORING OF TEMPERATURE IN ANESTHETIZED PATIENTS BY INSERTING THE PROBE INTO THE ESOPHAGUS OR THE RECTUM." WITHOUT A SAMPLE OR A REPORTED LOT NUMBER, A PHYSICAL ANALYSIS AND DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A REVIEW WAS PERFORMED OF THE LAST TWO WORK ORDERS FOR PART NUMBER 81-020412. NO DISCREPANCIES OR REJECTS WERE FOUND DURING THE MANUFACTURING PROCESS. AS PART OF THE MANUFACTURING PROCESS, A 100 PERCENT ELECTRIC LEAK TEST IS PERFORMED TO ENSURE THAT ALL PRODUCTS ARE IN COMPLIANCE FROM A FUNCTIONAL STANDPOINT. ANY DEFECTIVE UNITS ARE IMMEDIATELY SCRAPPED. ACTION POINT AND MATERIAL RELEASE REPORT LOGS WERE REVIEWED. NO SIMILAR SITUATIONS HAVE BEEN REPORTED. PREVENTIVE ACTION: NO PREVENTIVE ACTIONS HAVE BEEN IDENTIFIED AS PART OF THIS INVESTIGATION. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    A PATIENT WENT IN FOR AN MRI DUE TO THE POSSIBILITY OF A STROKE. THE PATIENT WAS INCOHERENT AT THE TIME OF THE MRI. A GENERAL PURPOSE TEMPERATURE PROBE WAS IN USE DURING THE PROCEDURE. THE PROBE CONNECTOR END WAS UNDER THE PATIENT'S RIGHT ARM PIT AREA. THE TIP OF THE PROBE WAS WRAPPED AROUND THE NECK TO THE LEFT SIDE OF THE HEAD IN THE OCCIPITAL AREA. THE PATIENT RECEIVED AN ELECTRICAL BURN UNDER THE RIGHT ARM NEAR HER ARMPIT. THE BURN IS THIRD-DEGREE. THE PATIENT FAMILY FEELS THEY SEE A BURN MARK ON THE LEFT SIDE OF HER SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252653 DEROYAL GENERAL PURPOSE PROBE 12FR THERMOMETER, ELECTRONIC, CLINICAL FLL DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other