BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEMP II

    MDR report key: 1644663 · Received March 26, 2010

    Report

    Report Number
    1644019-2010-00012
    Event Type
    Injury
    Date Received
    March 26, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 24, 2010
    Manufacturer
    ALCON-HOUSTON
    Product Code
    HQP
    PMA / PMN Number
    K820157
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR EVALUATION AND ROOT CAUSE ANALYSIS. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED; THIS IS THE FIRST EVENT REPORTED REGARDING THIS ISSUE FOR THIS FACILITY. THE DEVICE HISTORY RECORDS WERE REVIEWED. THE LOTS WERE RELEASED BASED ON ALCON'S ACCEPTANCE CRITERIA. HOWEVER, 2 SAMPLES OF CURRENT PRODUCT WERE OBTAINED FROM INVENTORY FOR REPRODUCING THE NONCONFORMANCE SCENARIO. TWO EXPERIMENTS WERE CONDUCTED, BOTH WITH THE GOAL OF GENERATING ENOUGH HEAT TO MELT THE "FINE TIP PREFORM" (PLASTIC FROM AROUND THE CAUTERY TIP): TIP FILAMENT WAS WIPED DOWN WITH THE ISOPROPYL ALCOHOL, 70% (IPA) USING STANDARD PIECE OF GAUZE. WITHOUT ALLOWING THE TIP TO DRY COMPLETELY, THE OPTEMP II WAS TURNED ON AND HELD IN THE ON POSITION FOR APPROXIMATELY FIVE (5) MIN. INITIALLY THE PRESENCE OF IPA, WITH THE HEAT OF THE OPTEMP, GENERATED A FIRE AT THE TIP FILAMENT ONLY. THE FLAME CAUSED THE IPA TO EVAPORATE IMMEDIATELY (LESS THAN 30 SEC) AND THE FLAME EXTINGUISHED W/O HUMAN INTERVENTION. NO MELTING WAS OBSERVED TO THIS POINT OF THE EXPERIMENT; THEREFORE, WITH THE SAMPLE STILL IN THE "ON" POSITION, THE TIP FILAMENT WAS TOUCHED TO THE IPA SOAKED GAUZE. THIS STARTED A CONTINUOUSLY BURNING FLAME, WHICH LATER HAD TO BE EXTINGUISHED USING HUMAN INTERVENTION. THE SAMPLE WAS HELD OVER THE FLAME WITH THE DEVICE STILL IN THE "ON" POSITION. CARE WAS TAKEN TO HOLD THE FINE TIP PREFORM AREA DIRECTLY IN THE FLAME. MELTING COULD NOT BE PRODUCED AFTER HAVING THE SAMPLE ON CONTINUOUSLY AND HELD TO A FLAME FOR FIVE (5) MINS. THE REPORT WAS NOT DUPLICATED WITH THIS EXPERIMENT. SIMILAR TO THE EXPERIMENT ABOVE, ALL THE SAME STEPS WERE TAKEN, EXCEPT THAT THE FILAMENT WAS MANUALLY MANIPULATED SO THAT THE TIP ACTUALLY TOUCHED THE FINE TIP PREFORM. ADDITIONALLY, THE 2ND EXPERIMENT WAS ALTERED IN THAT UNIT WAS HELD IN THE FLAME UNTIL IT BECAME INOPERABLE (APPROXIMATELY 10 MINS. ) NO MELTING OR DROPS OF RAW MATERIAL WAS OBSERVED DURING THE 2ND EXPERIMENT EITHER. ONCE AGAIN, THE CUSTOMER'S REPORT COULD NOT BE DUPLICATED. SEE THE ATTACHED PICTURE OF THE TESTED INVENTORY SAMPLE. THE FINE TIP PREFORM IS CONSTRUCTED OF HIGH IMPACT POLYSTYRENE RESIN (HIPS) WITH A MELTING POINT OF 215 DEGREES F. THE OPTEMP II IS RATED FOR 1300 DEGREES C/2372 DEGREES F; THEREFORE, TECHNICALLY, IS CAPABLE OF MELTING THE HIPS CONSTRUCTED COMPONENT, HOWEVER, IT IS INDETERMINABLE WHY THE CIRCUMSTANCES REPORTED BY THE CUSTOMER WAS UNABLE TO BE RECREATED. ROOT CAUSE: INDETERMINABLE; HOWEVER, THE SUPPLIER HAS BEEN REQUESTED TO REPORT ANY INFO TO ALCON THAT MAY LEAD TO DETERMINING A ROOT CAUSE FOR THIS ISSUE. CORRECTIVE ACTION: NONE IDENTIFIED, HOWEVER, THE INCOMING PRODUCT WILL BE MONITORED CLOSELY FOR ANY ISSUES SIMILAR TO THIS REPORT. THE PRODUCT WILL CONTINUE TO BE MONITORED PER ALCON APPROVED PROCEDURE AND PROCESSES. (B) (4)

    Description of Event or Problem · 1

    ADVERSE EVENT: BURN. MALFUNCTION: POWER CONDUCTION. CUSTOMER REPORTED DURING A PROCEDURE TO TREAT A SMALL LESION ON A PATIENT'S FINGER, THE PLASTIC FROM AROUND THE CAUTERY TIP MELTED AND FELL ONTO A GAUZE UNDER THE PATIENT'S FINGER. IT CAUSED THE GAUZE TO CATCH FIRE AND BURN 30% OF THE TIP OF PATIENT'S FINGER. ADDITIONAL INFORMATION IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEMP II UNIT, CAUTERY, THERMAL, BATTERY-POWERED HQP ALCON-HOUSTON 8065004603 59894900

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention CUSTOM PAK SURGICAL PAK