BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARCUT KNIVES

    MDR report key: 7056709 · Received November 23, 2017

    Report

    Report Number
    2523835-2017-00784
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    November 9, 2017
    Report Date
    February 16, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE OPENED KNIFE SAMPLE WAS RECEIVED UNPROTECTED AND LOOSE IN A BLISTER PACKAGE FOR THE REPORT OF BEING DULL AND ASSOCIATED WITH POSSIBLE ZONULAR DAMAGE. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND WAS FOUND TO BE NONCONFORMING WITH A DAMAGED TIP AND A DAMAGED CUTTING EDGE. PENETRATION TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD RELATED TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THAT THERE ARE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION PERFORMED. THE DAMAGE TO THE RETURNED SAMPLE IS CONSISTENT WITH DAMAGE THAT CAN OCCUR WHEN THE BLADE CONTACTS A HARD SURFACE SUCH AS THE PROTECTIVE BLADE TRAY WHEN THE PRODUCT IS IMPROPERLY REMOVED OR INSERTED AFTER USE, FROM IMPROPER HANDLING OR FROM CONTACT WITH ANOTHER INSTRUMENT DURING SURGERY OR SET-UP. THE EXACT ROOT CAUSE FOR THE DAMAGED KNIFE SAMPLE IS UNKNOWN THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY NONCONFORMANCE, SUCH AS THE DAMAGED CUTTING EDGE AND DAMAGED TIP EXHIBITED ON THE RETURNED OPENED SAMPLE, IS REMOVED FROM THE LOT AND SCRAPPED. FUNCTIONAL PENETRATION TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A KNIFE WAS DULL DURING CATARACT SURGERY. WHEN PUSHED, THE KNIFE POPPED THROUGH THE INCISION STRIKING THE LENS AND WAS BELIEVED TO CAUSE ZONULAR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834572 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 213613M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other