BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5114661 · Received September 30, 2015

    Report

    Report Number
    3009026057-2015-00034
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 30, 2015
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENSAR FSE REMOVED THE COVER TO THE PSU AND FOUND A DAMAGED/BURNED WIRE THAT PROVIDES POWER TO THE PC THAT IS INTERNAL TO THE PSU. THE ROOT CAUSE FOR THE BURNED WIRE IS THE SATA POWER SUPPLY CONNECTOR ON THE HARD DISK. IT IS MOST LIKELY THAT A SHORT CIRCUIT OCCURRED DIRECTLY IN THE CONNECTOR HOUSING. THIS ASSUMPTION WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE LENSAR FSE REMOVED THE COVER TO THE PSU AND FOUND A DAMAGED/BURNED WIRE THAT PROVIDES POWER TO THE PC THAT IS INTERNAL TO THE PSU. THE ROOT CAUSE FOR THE BURNED WIRE IS THE SATA POWER SUPPLY CONNECTOR ON THE HARD DISK. IT IS MOST LIKELY THAT A SHORT CIRCUIT OCCURRED DIRECTLY IN THE CONNECTOR HOUSING. THIS ASSUMPTION WAS CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO A LENSAR FSE VIA PHONE ON (B)(6) 2015 THAT THE SYSTEM WAS SMOKING AND IT SET OFF THE SMOKE DETECTORS IN THE OPERATING ROOM AND THE FACILITY WAS EVACUATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO A LENSAR FSE VIA PHONE ON (B)(6)15 THAT THE SYSTEM WAS SMOKING AND IT SET OFF THE SMOKE DETECTORS IN THE OR AND THE FACILITY WAS EVACUATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646478 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC 70-00005-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1