BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2081380 · Received April 22, 2011

    Report

    Report Number
    2523835-2011-00032
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 25, 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
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION TEST VALUES FOR THE LOT MET SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO MANUFACTURE ACCEPTANCE CRITERIA. THE ROOT CAUSE FOR THE DULL KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A KNIFE WAS DULL DURING A PROCEDURE AND THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE KNIFE WAS ATTEMPTED TO BE USED ON A PATIENT HOWEVER IT WAS DULL. ANOTHER BLADE WAS USED TO COMPLETE THE CASE WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065921541 831016M

    Patients

    Seq Age Sex Outcome Treatment
    1