BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3013114 · Received March 15, 2013

    Report

    Report Number
    1644019-2013-00026
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS NOT YET BEEN REC'D FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT WHILE LOOKING AT THE TROCAR CANNULA UNDER THE MICROSCOPE ONCE IT WAS INSERTED INTO THE EYE, HE NOTICED THE VALVE WAS DAMAGED AND WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110075 CUSTOM PAK CONVENIENCE KIT KYG ALCON PRECISION DEVICE - SINKING SPRING CUSTOM PAK 1308060H

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION VISION SYSTEM