BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT INTREPID KNIVES

    MDR report key: 8667810 · Received June 4, 2019

    Report

    Report Number
    2523835-2019-00239
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 21, 2019
    Report Date
    August 29, 2019
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OPENED KNIFE SAMPLE WAS RECEIVED LOOSE IN A BLISTER FOR THE REPORT OF HAVING A DULL BLADE. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND WAS FOUND TO BE NONCONFORMING WITH A DAMAGED TIP. PENETRATION TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE SAMPLE. RETURNED PHOTO NUMBER ONE SHOWS A KNIFE ON A TYVEK WHICH CONFIRMS THE REPORTED PRODUCT AND LOT NUMBERS FOR QS (B)(4). PHOTO NUMBER TWO SHOWS A KNIFE ON A TYVEK WHICH CONFIRMS THE REPORTED PRODUCT AND LOT NUMBERS FOR QS (B)(4). THE REPORTED ISSUE OF A DULL BLADE COULD NOT BE CONFIRMED FROM THE PHOTOS. 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 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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 IS NOT AVAILABLE FOR THIS REPORT. THIS IS THE SECOND OF TWO REPORTS FOR THIS FACILITY. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT TWO SEPARATE KNIVES WERE DULL DURING SURGERY. PATIENT IMPACT INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT ALTERNATE KNIVES WERE OBTAINED IN ORDER TO PERFORM THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461280 CLEARCUT INTREPID KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 280029M

    Patients

    Seq Age Sex Outcome Treatment
    1