BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT KNIVES

    MDR report key: 6012199 · Received October 7, 2016

    Report

    Report Number
    2523835-2016-00757
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 19, 2016
    Report Date
    January 3, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED KNIFE SAMPLE WAS RECEIVED BY MANUFACTURING FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED PER FACILITY PROCEDURE AND WAS FOUND TO BE NONCONFORMING WITH A DAMAGED TIP AND A DAMAGED CUTTING EDGE. PENETRATION AND SHARPNESS TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE SAMPLE. A REVIEW OF THE RELATED DEVICE HISTORY RECORDS FOR 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 PROVIDED LOT NUMBER FOR THE REPORTED COMPLAINT 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 AND 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. (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE THAT HAS NOT YET 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).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT A KNIFE DID NOT CUT AND THE TIP WAS DAMAGED. PROCEDURE DETAILS, PATIENT INVOLVEMENT AND PATIENT IMPACT INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE UNACCEPTABLE KNIFE TIP WAS NOTED PRIOR TO THE START OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664156 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 154196M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other