BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT KNIVES

    MDR report key: 8984008 · Received September 10, 2019

    Report

    Report Number
    2523835-2019-00394
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    July 1, 2019
    Report Date
    December 11, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OPENED KNIFE SAMPLE WAS RECEIVED LOOSE IN A BLISTER FOR THE REPORT OF BLUNT KNIFE. 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. PHOTOS ATTACHED TO THE PARENT COMPLAINT WERE REVIEWED BY THE MANUFACTURING SITE. THERE ARE SEVEN PHOTOS ATTACHED. THESE PHOTOS CONFIRM THE PRODUCT AND LOT NUMBERS FOR THIS FILE (QS (B)(4)) AND QS FILES: 1413574 AND 1418834. THE REPORTED ISSUE COULD NOT BE CONFIRMED FROM THE PHOTOS. 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 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).

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE THAT HAS NOT YET BEEN RECEIVED AT 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. THIS IS THE SECOND OF THREE REPORTS FROM THIS REPORTER FOR THIS REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT SIX KNIVES WERE DULL DURING SEPARATE CATARACT SURGERIES. ALTERNATE KNIVES WERE OBTAINED IN ORDER TO COMPLETE EACH PROCEDURE. THERE WAS NO IMPACT TO ANY PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780656 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 266055M

    Patients

    Seq Age Sex Outcome Treatment
    1