BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT KNIVES

    MDR report key: 19068630 · Received April 8, 2024

    Report

    Report Number
    2523835-2024-00587
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 21, 2024
    Report Date
    July 24, 2024
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    UDI-DI
    00000000000000
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN SECTIONS D.9. H.3. H.6 AND H.11 FIVE OPENED KNIVES, SOME BLADES NOT IN FOAM AT ALL AND SOME NOT IN FOAM PROPERLY WITH BLADE TIP OUT OF FOAM, IN A BAG IN BLISTERS WERE RECEIVED FOR THE REPORT OF DULL KNIVES. SAMPLES WERE VISUALLY INSPECTED AND SAMPLE 2, 3 AND 5 WERE FOUND TO BE CONFORMING. FUNCTIONAL PENETRATION TESTING WAS PERFORMED AND SAMPLE 2 WAS FOUND TO BE CONFORMING AND SAMPLE 3 AND 5 WAS NONCONFORMING. SAMPLE 1 AND 4 WERE FOUND TO BE NONCONFORMING, BENT TIP AND DAMAGED CUTTING EDGE WAS OBSERVED ON THE BLADE. PENETRATION TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE SAMPLE 1 AND 4. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBERS, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA THE RETURNED SAMPLE 3 AND 5 WAS FOUND TO BE FUNCTIONALLY NONCONFORMING, THEREFORE THE DULL KNIVES WERE CONFIRMED. THE ROOT CAUSE FOR THE DULL CUTTING EDGE IS RELATED TO THE ELECTROPOLISHING STEP IN THE MANUFACTURING PROCESS. THE RETURNED SAMPLE 2 WAS FOUND TO BE VISUALLY AND FUNCTIONALLY CONFORMING, THEREFORE DULL BLADES AS DESCRIBED IN THE COMPLAINT WAS NOT CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED FOR THE COMPLAINT AS DESCRIBED BY THE CUSTOMER. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION PERFORMED. THE DAMAGE TO THE RETURNED SAMPLE 1 AND 4 ARE CONSISTENT WITH DAMAGE THAT CAN OCCUR WHEN THE BLADE CONTACTS A HARD SURFACE SUCH AS THE PROTECTIVE BLADE TRAY WHEN PRODUCT IS IMPROPERLY REMOVED OR INSERTED AFTER USE, OR IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT DURING SURGERY OR SET-UP. THE DAMAGE SEEN ON THE RETURNED COMPLAINT SAMPLE COULD HAVE CONTRIBUTED TO THE CUSTOMERS REPORTED ISSUE OF DULL KNIVES. THE EXACT ROOT CAUSE FOR THE DAMAGED KNIFE SAMPLE IS UNKNOWN, THEREFORE SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. A NONCONFORMANCE INVESTIGATION IS CURRENTLY IN PROGRESS TO INVESTIGATE THE TREND IDENTIFIED FOR DULL CUTTING INSTRUMENTS. ALL KNIVES ARE 100 PERCENT INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY NONCONFORMANCE, SUCH AS THE DAMAGED TIP AND DAMAGED CUTTING EDGE 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING KNIFES WERE FOUND TO BE DULL DURING THE SURGERY. THE DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456345 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 167PW8 00000000000000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CUSTOM-PAK PACK.