BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORC

    MDR report key: 2143006 · Received June 20, 2011

    Report

    Report Number
    1222074-2010-00007
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 9, 2010
    Report Date
    June 16, 2011
    Manufacturer
    DORC INT'L BV
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED AND WAS CONCLUDED THAT THE MOST LIKELY CAUSE WAS THAT THE FIBER WASN'T FULLY GLUED IN THE CAPILLARY AND HANDPIECE HAVING A CONSEQUENCE THAT A SPACE AROSE BETWEEN THE FIBER AND CAPILLARY AND ALSO TO THE HANDPIECE, WHICH CAUSED THE LEAKING OF HUMIDITY DURING THE CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO DISTRIBUTOR THAT THE HANDLE OF A DORC ILLUMINATED LASER PROBED LEAKED LIQUID FROM HANDLE. DOCTOR WAS ABLE TO USE A SECOND PROBE FROM SAME LOT WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORC ILLUMINATED LASER PROBE HQF DORC INT'L BV 7410-ALC 926311

    Patients

    Seq Age Sex Outcome Treatment
    1