BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3102337 · Received April 30, 2013

    Report

    Report Number
    2523835-2013-00058
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Report Date
    April 4, 2013
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES HAVE BEEN RECEIVED FOR EVALUATION. SINCE NO LOT NUMBER WAS PROVIDED; A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT OVER RECENT MONTHS, MULTIPLE OCCURRENCES OF DULL KNIVES HAVE BEEN NOTED DURING AN UNSPECIFIED NUMBER OF PROCEDURES. IN EACH CASE, THE KNIFE WAS IMMEDIATELY REPLACED. THERE WAS NO PATIENT HARM REPORTED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188220 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1