BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUNCH D9.00MM

    MDR report key: 4692492 · Received April 9, 2015

    Report

    Report Number
    MW5042079
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 9, 2015
    Manufacturer
    MORIA
    Product Code
    HNJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A PENETRATING KERATOPLASTY PROCEDURE DONE. THE DONOR CORNEA WAS BEING PREPARED ON THE BACK TABLE. THE SURGEON AND SCRUB TECH WERE USING THE MORIA PUNCH D9.00MM, (B)(4), LOT 1141905 TO CUT THE CORNEA. AFTER CUTTING THE CORNEA, THE SYRINGE ON THE PUNCH WAS PUSHED AND THE CORNEA FLEW OFF OF THE DONOR PUNCH. THE SURGEON, SCRUB TECH, CIRCULATOR AND CRNA ALL TRIED TO LOCATE THE CORNEA BUT WERE UNABLE TO FIND IT. NO INCISION ON THE PATIENT WAS MADE. NO ADVERSE AFFECT TO PATIENT. THE CASE WAS CANCELLED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233834 PUNCH D9.00MM HNJ MORIA PUNCH D9.00MM 1141905

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR