BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3177132 · Received June 12, 2013

    Report

    Report Number
    2523835-2013-00077
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 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
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE WAS RETURNED. EVALUATION OF THE SAMPLE SHOWED THE FOLLOWING RESULTS: THE SAMPLE WAS EXAMINED USING (B)(4) MAGNIFICATION AND FOUND TO HAVE A DAMAGED TIP. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. HOW OR WHEN THE BLADE BECAME DAMAGED CANNOT BE DETERMINED. THE DAMAGE TO THE RETURNED SAMPLE IS CONSISTENT WITH DAMAGE THAT CAN OCCUR WHEN THE BLADE CONTACTS ANOTHER SURFACE PRIOR TO USE. SOME POTENTIAL CAUSES COULD BE REUSE, IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT ON THE INSTRUMENT TRAY DURING PROCEDURE SETUP. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF (B)(4) MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. SHARPNESS TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A DULL KNIFE DURING SURGERY. THE KNIFE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266601 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982265 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1