BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC-5000

    MDR report key: 5138139 · Received October 8, 2015

    Report

    Report Number
    3002807715-2015-00051
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    January 21, 2015
    Report Date
    September 7, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 9/7/2015 NIDEK INC. CLINICAL SPECIALIST RECEIVED AN EMAIL FROM NIDEK (B)(4) MDR TEAM REGARDING THE MAUDE REPORT AT THE FDA SITE. AS PER THE REPORT PATIENT SUBMITTED THE VOLUNTARY REPORT TO THE FDA AND THE PATIENT REPORTED THAT HE/SHE HAD PRK SURGERY ON HIS/HER EYE BY DOCTOR USING NIDEK EC-5000. PATIENT REPORTED THAT HIS/HER VISION GOT TERRIBLE AFTER THE SURGERY AND HE/SHE HAD DIFFICULTIES IN HIS EYE. PATIENT WAS NOT SURE THIS COULD BE EITHER DUE TO DEVICE FAILURE OR THE USER ERROR. PATIENT ALSO DID NOT PROVIDE ANY INFORMATION ABOUT THE SERIAL NUMBER OR ANY OTHER DETAILS OF THE EC-5000. AT THIS TIME NIDEK INC. DO NOT HAVE ANY ADDITIONAL DETAILS OF THE PATIENT INJURY. THE DEVICE HAS NOT BEEN EVALUATED SINCE THE DETAILS REGARDING THE SERIAL NUMBER OR THE NAME OF THE USER FACILITY USING THE DEVICE ARE NOT AVAILABLE. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AS A DUE DILIGENCE NIDEK INC. WOULD LIKE TO SUBMIT THE MEDWATCH FORM FOR THIS ISSUE.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED AN EMAIL FROM NIDEK (B)(4) MDR TEAM ON 9/7/2015 REGARDING A NOTIFICATION FROM FDA. FDA RECEIVED A MAUDE FORM FROM PATIENT ON (B)(6) 2015 REGARDING A COMPLAINT FOR NIDEK EC-5000. MDR REPORT (B)(4). REPORT NUMBER: MW5055586. AS PER THE MAUDE PATIENT REPORTED THAT "PRK EYE SURGERY WAS PERFORMED ON MY EYES (B)(6) 2014. THE DOCTOR NEVER SAID A WORD TO ME BEFORE, DURING OR AFTER SURGERY. THE AIDE THAT WAS ASSISTING HIM PREPPED ME FOR THE SURGERY, THEN DOCTOR A FEW MINUTES LATER STARTED TO LASER MY EYE. HE NEVER SAID OR INFORMED ME ABOUT A FIXATION LIGHT; NEITHER DID I SEE ANY FIXATION LIGHT. MY PREVIOUS LASIK I HAD 20 SOME YEARS PRIOR HAD A FIXATION LIGHT WHICH I WAS INSTRUCTED TO LOOK AT. THAT SURGERY WAS SUCCESSFUL; THE PARK THAT WAS DONE WAS BECAUSE MY EYES WERE GETTING A LITTLE NEARSIGHTED, MAYBE REGRESSION SO I WANTED A TOUCH UP. MY VISION IS TERRIBLE AND I'M HAVING OTHER EYE DIFFICULTIES. I'M NOT SURE IF THE LASER WASN'T WORKING PROPERLY OR IT'S THE DOCTOR THAT RUINED MY EYES. I REPORTED THIS LASER, NIDEK EC5000 BACK BUT DON'T BELIEVE ANYTHING WAS DONE NOR DO I HAVE ACCESS TO THE MODEL NUMBER OF DEVICE OR ANY INFO ON IT LIKE WHEN AND WHO LAST SERVICED IT. I'D REALLY WOULD LIKE TO KNOW. (B)(6) HAS BEEN REPORTED TO (B)(6) BECAUSE THESE ARE MY EYES, AT LEAST THERE WERE NOT ANYMORE, AND I DON'T TAKE THIS NEGLIGENCE ON SOMEBODY PART LIGHTLY. THANK YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665207 EC-5000 EXCIMER LASER HQF NIDEK CO., LTD. EC-5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1