BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3802257 · Received March 24, 2014

    Report

    Report Number
    2523835-2014-00035
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    ALCON PRECISION DEVICE
    Product Code
    HNN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED AND NO EVIDENCE FOR NONCONFORMITY COULD BE FOUND IN THE LOT RECORD REVIEW, THE ROOT CAUSE FOR THE DEFECT "DULL BLADE" REPORTED BY THE CUSTOMER CANNOT BE DETERMINED. SOME POTENTIAL CAUSES ARE REUSE, IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATOR'S USING A MINIMUM OF (B)(4) MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS SUCH AS DAMAGED TIPS AND DULL 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. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THE BLADE OF THE KNIFE WAS DULL AND THE BLADE SEEMED TO BE BURRED DURING SURGERY. THE PROBLEM WAS SOLVED AFTER REPLACING THE KNIFE WITH AN ALTERNATE ONE. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171334 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE 8065982865 938143M

    Patients

    Seq Age Sex Outcome Treatment
    1