BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2191898 · Received July 22, 2011

    Report

    Report Number
    2523835-2011-00121
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS UNLIKELY THAT DAMAGE OCCURRED DURING THE MFG PROCESS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE KNIVES PROVIDED IN THE CUSTOM PACK LOOKED STRANGE AND WERE NOT SHARP. AS A CONSEQUENCE, THE BLADE WOULD NOT CUT DURING THE PROCEDURE. PT IMPACT IS UNK. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065921541 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1