BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPS FX PHACO HANDPIECE

    MDR report key: 5295072 · Received December 14, 2015

    Report

    Report Number
    3006695864-2015-00919
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    November 11, 2015
    Report Date
    January 11, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2015. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER: IN MDR FOLLOW UP #1, THE DATE RECEIVED OF 12/15/2016 WAS LISTED; HOWEVER, THE CORRECT DATE IS 12/15/2015. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: AT THE TIME OF THIS REPORT, THE DATE OF THE EVENT IS UNKNOWN. (B)(6). CUSTOMER DID NOT REQUEST FOR A FIELD SERVICE SPECIALIST VISIT TO THE SITE. ONLY AN ACCESSORY EXCHANGE WAS REQUESTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAULTY HANDPIECE-BARE WIRE ON THE HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825360 ELLIPS FX PHACO HANDPIECE PHACO HANDPIECE HQC ABBOTT MEDICAL OPTICS 690880

    Patients

    Seq Age Sex Outcome Treatment
    1