BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1760989 · Received July 9, 2010

    Report

    Report Number
    2028159-2010-01160
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 11, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "PLUGS WOULD NOT FIT IN CANNULA" (FITTING PROBLEM). A CUSTOMER REPORTED THE DOCTOR HAD DIFFICULTY, DURING SURGERY, TRYING TO GET 23 GAUGE PLUGS INTO THE CANNULA. THE PLUGS WOULD NOT STAY IN THE CANNULAS. ANOTHER PLUG WAS USED AND THE CASE WAS COMPLETED. THE FACILITY RETAINED THE PLUGS AND CANNULAS AND WILL SEND THEM IN FOR IN-HOUSE EVAL. THERE WAS NO PT HARM OR PROCEDURAL CHANGE REPORTED. ON JUNE 29, 2010, THE FACILITY MEDWATCH FORM WAS REC'D. THE FACILITY RISK MGMT REPORTED THE PLUGS DID NOT FIT IN THE CANNULAS (THEY WERE TOO BIG). THE PT WAS NOT HARMED BY THIS EVENT; HOWEVER, THE PHYSICIAN WAS QUITE FRUSTRATED. ANOTHER KIT FROM THE SAME MFR WAS USED FOR THE CASE AND THE KIT WITH THE NON-CONFORMING PLUGS WAS SAVED AND WILL BE SENT BACK TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS 9023848X

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR