BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT KNIVES

    MDR report key: 6076295 · Received November 3, 2016

    Report

    Report Number
    2523835-2016-00815
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Report Date
    May 25, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    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. 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 (B)(4).

    Additional Manufacturer Narrative · 1

    TWO OPENED KNIVES WERE RECEIVED IN A PLASTIC BAG FOR THE REPORT OF DID NOT CUT. THE RETURNED SAMPLES WERE VISUALLY INSPECTED AND WERE FOUND NON-CONFORMING WITH DAMAGED TIPS AND 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 IS ONE ADDITIONAL COMPLAINT 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 SAMPLES 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. (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RETURNED FOR EVALUATION FOR THE REPORT OF BENT TIP; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. 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 THERE IS ONE ADDITIONAL COMPLAINT ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. NO SAMPLE WAS RETURNED AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED PRODUCT WAS RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA, THEREFORE THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT THERE WERE TWO KNIVES THAT DID NOT CUT DURING A PROCEDURE. THE CASE WAS COMPLETED USING AN ALTERNATE KNIFE WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728615 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 150689M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other