BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT KNIVES

    MDR report key: 4890431 · Received July 6, 2015

    Report

    Report Number
    2523835-2015-00677
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 3, 2015
    Report Date
    November 29, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE KNIFE SAMPLE WAS RECEIVED BY MANUFACTURING IN AN OPENED BLISTER PACKAGE. THE SAMPLE WAS INSPECTED PER FACILITY PROCEDURE AND WAS DETERMINED TO BE VISUALLY NONCONFORMING WITH A DAMAGED TIP AND CUTTING EDGE. PENETRATION AND SHARPNESS TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE SAMPLE. THE FINAL CUSTOMER LOT NUMBER WAS IDENTIFIED. ONE COMPONENT KNIFE LOT WAS USED TO MAKE UP THE CUSTOMER'S FINAL LOT. A REVIEW OF THE RELATED DEVICE HISTORY RECORDS HAS BEEN PERFORMED AND NO ANOMALIES WERE FOUND. THE PRODUCT WAS RELEASED ACCORDING TO THE MANUFACTURER'S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION REVEALED THAT THIS WAS THE FOURTH COMPLAINT RECEIVED AGAINST THE REPORTED FINAL LOT. HOW THE BLADE BECAME DAMAGED CANNOT BE DETERMINED FROM THE EVALUATION. 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 MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED BY MANUFACTURING THAT HAS NOT YET BEEN EVALUATED. 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. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT WHILE TRYING TO MAKE THE INCISION DURING A CATARACT PROCEDURE, THE KNIFE WAS BLUNT. AN ALTERNATE KNIFE WAS OBTAINED IN ORDER TO CONTINUE TO THE INCISION. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434399 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 997946M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other