BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY #3 CLAMP

    MDR report key: 2150569 · Received June 22, 2011

    Report

    Report Number
    1925223-2011-00019
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    April 12, 2011
    Report Date
    June 22, 2011
    Manufacturer
    HERAEUS KULZER, LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR HAD A #3 IVORY CLAMP BREAK ON HER DURING AN OPERATING ROOM SEDATION CASE ON A CHILD. THIS HAPPENED APPROX (B)(6) AGO. THE DEALER REP LEARNED OF THIS FROM HER SERVICE TECH ABOUT (B)(6) AGO. SHE WANTED TO WAIT UNTIL SHE COULD SPEAK TO THE DOCTOR FACE TO FACE, WHICH OCCURRED YESTERDAY. A MESSAGE HAS BEEN LEFT WITH THE DOCTOR'S OFFICE FOR DETAILED INFO. THE DEALER REP ADVISED THAT THE DOCTOR ONLY ORDERS IVORY #3 CLAMPS AND RE-ORDERS THEM ON A REGULAR BASIS. THE DOCTOR LIGATED ONE SIDE OF THE CLAMP. THE CLAMP BROKE DURING A SEDATION CASE AND THE FEMALE CHILD SWALLOWED THE PIECE THAT WAS NOT LIGATED. THE BROKEN CLAMP PASSED WITHOUT ANY FURTHER COMPLICATIONS. THE MOTHER OF THE PT IS NOT THREATENING TO SUE THE DOCTOR FOR NEGLIGENCE. ACCORDING TO THE DEALER REP, THE DOCTOR HAS OFFERED TO PAY THE CHILD'S HOSPITAL BILLS, BUT THE MOTHER HAS NOT PROVIDED THEM FOR THE DOCTOR. DEALER REP INQUIRED IF THERE WAS ANYTHING THAT COULD HAVE INDICATED WHEN A CLAMP HAS DETERIORATED TO THE POINT OF NEEDING TO BE REPLACED. ADVISED THAT THERE IS USUALLY NO SIGN OF FATIGUE OR INDICATION THAT THE CLAMP MAY FAIL. IT WAS EXPLAINED THAT THE CLAMPS HAVE A ONE YEAR WARRANTY BUT REPEATED STERILIZATION AND USE CAN FATIGUE THE METAL. THE OFFICE DOES NOT HAVE THE BROKEN PIECE THAT WAS SWALLOWED OR THE PIECE THAT WAS LIGATED TO LOOK UP A SERIAL NUMBER OR FOR EVAL. PER DEALER REP, THE DOCTOR SPOKE TO A COLLEAGUE WHO SAID THAT HE HAS HAD SEVERAL IVORY CLAMPS BREAK AND HE BEGAN LIGATING THE CLAMPS TO PREVENT THIS. DEALER REP ALSO STATED THAT THE DOCTOR HAS HAD 2 MORE CLAMPS BREAK RECENTLY AND HAS SWITCHED TO HU-FRIEDY CLAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY #3 CLAMP RUBBER DAM CLAMP EEF HERAEUS KULZER, LLC 50057322

    Patients

    Seq Age Sex Outcome Treatment
    1 Other