BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALOSA KIT

    MDR report key: 11847585 · Received May 19, 2021

    Report

    Report Number
    3002808441-2021-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 18, 2021
    Product Code
    HNQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THE END OF THE PHACO CHOPPER / MUSHROOM MANIPULATOR BROKE OFF INSIDE A PATIENT'S EYE AND SAFELY REMOVED. THE MUSHROOM/CHOPPER IS ITEM NUMBER MMSU1221 AND IS A COMPONENT OF THE MALOSA KIT, REF: MMK928, NEWMEDICA PHACO INSTRUMENT WITH CAPSULORHEXIS. WHILE THE EVENT WAS SPECIFIC TO A SURGICAL KIT DISTRIBUTED IN THE (B)(4), THIS MUSHROOM/CHOPPER IS ALSO A COMPONENT IN SURGICAL KITS DISTRIBUTED IN THE USA.

    Description of Event or Problem · 1

    PHACO CHOPPER / MUSHROOM MANIPULATOR COMPONENT OF THE MALOSO KIT, NEWMEDICA PHACO INSTRUMENT WITH CAPHEX, BROKE OFF INSIDE A PATIENT'S EYE. IT WAS THE CHOPPER END THAT BROKE OFF AND WAS REMOVED SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749669 MALOSA KIT NEWMEDICA PHACO INSTRUMENT WITH CAPHEX HNQ 3359605

    Patients

    Seq Age Sex Outcome Treatment
    1