BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICOWAY

    MDR report key: 9891749 · Received March 27, 2020

    Report

    Report Number
    1218402-2020-00022
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 27, 2020
    Product Code
    GEX
    PMA / PMN Number
    K191685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2020, DYNAMIC MEDICAL TECHNOLOGIES INC, (DMT), A DISTRIBUTOR OF CANDELA DEVICES IN TAIWAN, REPORTED TO A (B)(6) EMPLOYEE IN THE REGION VIA EMAIL, THAT THERE WAS AN ISSUE WITH A PICOWAY 532 RESOLVE HANDPIECE. WHEN USING A 532NM LOW-ENERGY RESOLVE HANDPIECE, THE ENERGY WAS FOUND TO BE TOO HIGH. FURTHER EVALUATION BY THEIR ENGINEER INDICATED THAT THE HANDPIECE WAS MISSING AN ATTENUATOR INSIDE, AND THE ENERGY OUTPUT WAS SIX TIMES HIGHER THAN NORMAL AS REPORTED BY DMT. FOLLOW-UP INDICATED THAT THIS DEVICE WAS IN USE AT THEIR CUSTOMER SITE AND THE DOCTOR SAW AN UNEXPECTED PATIENT RESULT. NO FURTHER PATIENT IMPACT INFORMATION IS AVAILABLE; ADDITIONAL INFORMATION WAS SOLICITED AND DUE DILIGENCE EFFORT EXHAUSTED. THE CASE WILL BE RE-ASSESSED UPON RECEIPT OF NEW AND/OR RELEVANT INFORMATION. REVIEW AND INVESTIGATION OF THE AVAILABLE DATA INDICATE THAT THIS MALFUNCTION MAY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY REQUIRING MEDICAL INTERVENTION; THEREFORE, THIS EVENT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354292 PICOWAY PICOWAY GEX 9914-00-9060

    Patients

    Seq Age Sex Outcome Treatment
    1