BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT KNIVES

    MDR report key: 6166450 · Received December 12, 2016

    Report

    Report Number
    2523835-2016-00917
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 16, 2016
    Report Date
    March 14, 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
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.4., E.1., AND H.4.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.10., H.3., H.6., AND H.10. ONE OPENED KNIFE WAS RECEIVED LOOSE IN A TRAY FOR THE REPORT OF BLUNT. KNICKS WERE OBSERVED ON THE TRAY THE PRODUCT WAS RECEIVED IN. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND WAS FOUND NON-CONFORMING WITH DAMAGED CUTTING EDGES. PENETRATION AND SHARPNESS TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE 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 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 PRODUCT IS IMPROPERLY REMOVED OR INSERTED AFTER USE, OR IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT DURING SURGERY OR SET-UP. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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 · 1

    A CUSTOMER REPORTED THAT A KNIFE WAS BLUNT DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818479 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 159802M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other