BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3834701 · Received May 13, 2014

    Report

    Report Number
    3004378299-2014-00028
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 3, 2012
    Report Date
    May 12, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K091909
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO A DAMAGE IN THE PUMPING CHAMBER AND ROD CRYSTAL. AFTER THE REPLACEMENT OF THESE TWO COMPONENTS, THE LASER SYSTEM RESTARTED TO WORK. THIS EVENT OCCURRED ON (B)(6) 2012. AT THAT TIME, QUANTA SYSTEM WAS INFORMED ABOUT IT BY THE SERVICE WORK ORDER (B)(4) FROM OUR DISTRIBUTOR, RECORDED ON OUR CLAIM N DEGREE 284 / (B)(6) 2012. IN ACCORDANCE WITH OUR MDR PROCEDURE, IN EFFECT AT THAT TIME, AND IN ACCORDANCE WITH A LATER RETROSPECTIVE REVIEW, WITH THE INFORMATION AVAILABLE AT THE TIME QUANTA SYSTEM DID NOT EVALUATE IT AS A MDR. ON DATE (B)(6) 2014 QUANTA SYSTEM RECEIVED ADDITIONAL INFORMATION BY DISTRIBUTOR: A PATIENT CLAIMS THAT, BECAUSE THE LASER DID NOT FIRE, BEFORE THE TREATMENT THE DOCTOR DECIDED TO DO AN OPEN PROCEDURE AND HE SUFFERED COMPLICATIONS BECAUSE OF THAT. THE LASER WAS NEVER USED ON THE PATIENT, AND WE ARE UNAWARE ABOUT WHY THE DOCTOR DECIDED ANYWAY TO DO AN OPEN PROCEDURE. APPARENTLY THE PATIENT UNDERWENT A TRADITIONAL OPEN SURGERY INTERVENTION (WITHOUT THE LASERS) WITH COMPLICATIONS. HOWEVER, ALTHOUGH THE EVEN IS REPORTABLE FOR THE FDA RULES, THERE IS NO PHYSICAL CORRELATION AT ALL BETWEEN THE LITHO LASER AND THE PATIENT'S POST OPERATIVE HEALTH STATUS.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAD THE FOLLOWING PROBLEM: "NO POWER OUTPUT". THIS EVENT OCCURRED ON (B)(6) 2012. AT THAT TIME QUANTA SYSTEM WAS INFORMED ABOUT IT BY THE SERVICE WORK ORDER 12-0090 FROM OUR DISTRIBUTOR, RECORDED ON OUR CLAIM N DEGREE 284 / (B)(6) 2012. IN ACCORDANCE WITH OUR MDR PROCEDURE, IN EFFECT AT THAT TIME, AND IN ACCORDANCE WITH A LATER RETROSPECTIVE REVIEW, WITH THE INFORMATION AVAILABLE AT THE TIME QUANTA SYSTEM DID NOT EVALUATE IT AS A MDR. ON DATE (B)(6) 2014 QUANTA SYSTEM RECEIVED ADDITIONAL INFORMATION BY DISTRIBUTOR: A PATIENT CLAIMS THAT, BECAUSE THE LASER DID NOT FIRE, BEFORE THE TREATMENT, THE DOCTOR DECIDED TO DO AN OPEN PROCEDURE. APPARENTLY, THE PATIENT UNDERWENT A TRADITIONAL OPEN SURGERY INTERVENTION (WITHOUT THE LASERS) WITH COMPLICATIONS. HOWEVER, ALTHOUGH THE EVEN IS REPORTABLE FOR THE FDA RULES, THERE IS NO PHYSICAL CORRELATION AT ALL BETWEEN THE LITHO LASER AND THE PATIENT'S POST OPERATIVE HEALTH STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285447 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. LITHO

    Patients

    Seq Age Sex Outcome Treatment
    1