BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZLASE SOFT TISSUE DENTAL LASER

    MDR report key: 971967 · Received December 28, 2007

    Report

    Report Number
    2027755-2007-00003
    Event Type
    Malfunction
    Date Received
    December 28, 2007
    Date of Event
    November 29, 2007
    Report Date
    December 28, 2007
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Product Code
    GEX
    PMA / PMN Number
    K061898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A DEVICE MALFUNCTION. THERE WAS NO PT INJURY. ONCE THIS DEVICE WAS RECEIVED AT BIOLASE, IT WAS SENT THROUGH EXTENSIVE TESTING AND ERROR COULD NOT BE DUPLICATED. ROOT CAUSE OF FAILURE IS UNK AT THIS TIME.

    Description of Event or Problem · 1

    IN 2007, REPORTER CALLED AND REPORTED TO BIOLASE SVC DEPT THAT HE WAS EXPERIENCING AN ISSUE WITH HIS EZLASE. HE CONTINUED BY STATING THAT THE LASER WOULD FIRE ON ITS OWN. WHEN ATTEMPTING TO ENGAGE THE "E" STOP SWITCH, THERE WAS NO RESPONSE. ALSO THE UNIT WOULD SWITCH ITSELF FROM STANDBY TO READY MODE BY ITSELF. REPORTER STATED THAT THIS HAS HAPPENED A COUPLE OF TIMES AND ONCE WITH A PT IN THE CHAIR. NO PT INJURY WAS REPORTED. ON 12/27/07, (QA/RA MGR) AND (IN-HOUSE SVC ENGINEER) TO GATHER FURTHER INFO. QUESTIONS WERE ASKED LIKE IS THERE ANY WIRELESS COMMUNICATION DEVICES PRESENT, IS THERE ANY TYPE OF DEVICES USED IN THE OPERATORY THAT ARE OPERATED ON BLUE TOOTH TECHNOLOGY. REPORTER RESPONDED "NO" TO ALL MY QUESTIONS. ALSO REPORTER STATED REGARDING THE "E" STOP SWITCH THAT HE MAY HAVE NOT BEEN PRESSING HARD ENOUGH TO ENGAGE. QA/RA MGR ASKED THE REPORTER IF HE HAD TO RESET THE "E" STOP SWITCH TO USE THE LASER AND THE ANSWER WAS NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZLASE SOFT TISSUE DENTAL LASER EZLASE GEX BIOLASE TECHNOLOGY, INC. 7400001

    Patients

    Seq Age Sex Outcome Treatment
    1