BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICASSO LITE DENTAL LASER SYSTEM

    MDR report key: 4658388 · Received March 27, 2015

    Report

    Report Number
    3007625547-2015-00001
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 25, 2015
    Manufacturer
    AMD GROUP LLC
    Product Code
    GEX
    PMA / PMN Number
    K102359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LASER UNIT DID NOT MALFUNCTION. BASE DON THE DISCUSSION WITH THE CUSTOMER, IT IS CLEAR THAT DR (B)(6) DID NOT FOLLOW APPROPRIATE SAFETY GUIDANCE AS INDICATED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    DISTRIBUTOR NOTIFIED AMD LASERS ON (B)(4) 2015 THAT A CUSTOMER OF THEIRS HAD CONTACTED THEM REGARDING "ILL FITTING SAFETY GLASSES AND A LASER BEAM RETINAL BURN." AFTER RECEIVING THE INFO, THE CUSTOMER WAS CONTACTED VIA PHONE ON (B)(6) 2015 TO DISCUSS THE CIRCUMSTANCES OF THE EVENT. CUSTOMER HAD PURCHASED THE LASER UNIT APPROX 1 YEAR PRIOR TO THE EVENT ((B)(6) 2014), HAD TAKEN THE LASER SAFETY TRAINING ((B)(4)) INCLUDED WITH THE DEVICE BUT HAD NOT USED THE LASER ON A PT UNTIL THE DATE OF THE EVENT. CUSTOMER ALSO INDICATED THAT THEY HAD REGISTERED FOR THE "HANDS ON" LASER SAFETY CLASS BEFORE THE EVENT BUT HAD NOT TAKEN THE COURSE AT THE TIME OF THE EVENT. THE CUSTOMER WAS INITIATING THE OPTICAL FIBER TIP WHEN THE INJURY OCCURRED. THIS WAS APPROX 10 MONTHS SINCE COMPLETION OF THE LASER SAFETY TRAINING. THE CUSTOMER WAS USING THE STANDARD ADULT LASER SAFETY GOGGLES AT THE TIME OF THE EVENT. CUSTOMER MENTIONED THAT BASED ON HOW THE GOGGLES FIT ON THE BRIDGE OF HER NOSE, THERE WAS A 1/2 INCH GAP BETWEEN HER FACE AND THE BOTTOM OF THE LENS. AS SHE WAS INITIATING THE FIBER TIP, SHE LOOKED DOWN THROUGH THE GAP DIRECTLY AT THE FIBER TIP AS THE LASER UNIT ACTIVATED, WHICH CAUSED A MINOR RETINAL BURN. CUSTOMER VISITED AN OPHTHALMOLOGIST AFTER THE EVENT TO HAVE HER EYES EXAMINED. THE OPHTHALMOLOGIST INDICATED THAT THERE WAS A MINOR RETINAL BURN BUT THAT IT WOULD HEAL WITHIN SEVERAL DAYS AND THAT THERE WOULD NOT BE ANY RESIDUAL DAMAGE. CUSTOMER INDICATED THAT THEY HAVE USED THE LASER SYSTEM AT LEAST ONE ADDITIONAL TIME AFTER THE EVENT TO TREAT A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205039 PICASSO LITE DENTAL LASER SYSTEM GEX AMD GROUP LLC PICASSO LITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other