BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT INTREPID KNIVES

    MDR report key: 8713632 · Received June 19, 2019

    Report

    Report Number
    2523835-2019-00267
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Report Date
    September 24, 2019
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE HAS BEEN RETURNED FOR EVALUATION FOR THE REPORT OF BLADES WERE DULL THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT THEREFORE, LOT HISTORY AND COMPLAINT HISTORY REVIEWS COULD NOT BE CONDUCTED. A PHOTO ATTACHED TO THE PARENT COMPLAINT WAS REVIEWED BY THE MANUFACTURING SITE. THE PHOTO CONFIRMS THE REPORTED PAK PRODUCT NUMBER AND PAK LOT NUMBER FOR QS (B)(4). AS A SAMPLE WAS NOT RETURNED AND NO LOT INFORMATION IS AVAILABLE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT 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. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFORMATION HAS 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. THIS IS THE THIRD OF THREE COMPLAINTS FOR THIS REPORTER. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT MULTIPLE KNIFE BLADES WERE DULL DURING SURGERIES. PATIENT IMPACT INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE DULL KNIVES WERE NOTED DURING SEPARATE UNCONFIRMED SURGERY DATES. THE DULL KNIVES REQUIRED ADDITIONAL PUSH IN ORDER TO CUT. THERE WAS NO IMPACT TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505245 CLEARCUT INTREPID KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1