BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT KNIVES

    MDR report key: 6119609 · Received November 21, 2016

    Report

    Report Number
    2523835-2016-00848
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    February 13, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IS PROVIDED IN MODEL #/LOT #, EVALUATION CODES AND ADDITIONAL MFR NARRATIVE. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION FOR THE REPORT OF PRODUCT DID NOT CUT; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCTS ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THERE ARE FOUR ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. BECAUSE A SAMPLE WAS NOT RETURNED AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCTS ACCEPTABLE CRITERIA, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X 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).

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE KNIFE DID NOT CUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767972 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 139758M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other