BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM

    MDR report key: 7447317 · Received April 20, 2018

    Report

    Report Number
    1222074-2018-00089
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    April 24, 2015
    Report Date
    April 24, 2015
    Manufacturer
    DUTCH OPTHALMIC RESEARCH CENTER BV
    Product Code
    HQE
    UDI-DI
    08717872019000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION SHOWED THAT ON THE BACK OF THE INNER KNIFE IS SOME GLUE. THIS IS EXACTLY THE PLACE WHERE THE O-RING MUST SEAL THE INNER KNIFE AND THE CAP. ASSUMING WORST CASE DURING SURGERY, AIR BUBBLES OBSERVED AT THE PROBE. THIS MAY CAUSE INJURY TO THE PATIENT. HENCE IT IS REPORTABLE. THE RISK IS POSSIBLE INJURY BY MICROBIAL, VIRAL OR PRION INFECTION (PATIENT HARM) THIS REPORTABLE EVENT WAS IDENTIFIED DURING A VOLUNTARY RETROSPECTIVE REVIEW OF ALL COMPLAINTS SINCE 2015 BY THE MANUFACTURER (DUTCH OPHTHALMIC RESEARCH CENTRE B.V.). DETAILS OF THIS ACTIVITY WERE DISCUSSED WITH CDRH OFFICE OF COMPLIANCE ((B)(6)) DURING A TELE-CONFERENCE ON (B)(6) 2017. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED. THIS COMPLAINT HAS NOW BEEN CLOSED.

    Description of Event or Problem · 1

    (B)(6) HAS REPORTED THE FOLLOWING: THE MEMBRANE OF THE CUTTER OF THE KIT ARE DEFECT SO THAT AIR IS ENTERING THE EYE AND BUBBLES ARE CAUSED. ALL INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290137 DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM HQE DUTCH OPTHALMIC RESEARCH CENTER BV 2000368064 08717872019000

    Patients

    Seq Age Sex Outcome Treatment
    1