BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM-PAK SURGICAL PROCEDURE PACK

    MDR report key: 5568626 · Received April 11, 2016

    Report

    Report Number
    1644019-2016-00648
    Event Type
    Malfunction
    Date Received
    April 11, 2016
    Report Date
    August 15, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND A TEMPORARY DEVIATION TO ADD COMPONENT (B)(4) AND REMOVE COMPONENT (B)(4) (THE COMPONENT (B)(4) IS THE COMPONENT RELATED TO THIS COMPLAINT.) THE CUSTOMER RETURNED FOURTEEN UNOPENED KNIVES FROM SUPPLIER LOT 3142856. THE KNIVES FROM THIS SUPPLIER LOT AND KNIVES FROM SUPPLIER LOT 3142431 WERE ISSUED TO THE CUSTOM PAK ASSOCIATED WITH THIS COMPLAINT. THE CUSTOMER DID NOT RETURN THE USED SUSPECT PRODUCT; THEREFORE, IT WAS UNKNOWN IF THE KNIFE REPORTED TO BE DULL DURING SURGERY WAS FROM SUPPLIER 3142856 OR SUPPLIER LOT 3142431. THE CUSTOMER ALSO RETURNED NON-SUSPECT PRODUCT FROM AN UNKNOWN CUSTOM PAK LOT FROM SUPPLIER LOT 3149252. A VISUAL INSPECTION OF THE RETURNED UNOPENED KNIVES WAS UNABLE TO CONFIRM THE CUSTOMER'S COMPLAINT FOR DULL BLADES; THEREFORE, THE SAMPLES WERE SENT TO THE SUPPLIER SO THAT A THOROUGH ASSESSMENT OF THE KNIVES COULD BE PERFORMED. THOUGH THE CUSTOMER'S COMPLAINT FOR DULL BLADES COULD NOT BE CONFIRMED IN THE LAB, THE MOST LIKELY ROOT CAUSE OF THE CUSTOMER'S COMPLAINT FOR DULL BLADES WAS AN ERROR THAT OCCURRED DURING THE SUPPLIER'S MANUFACTURING PROCESS. (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 THE SURGEON FOUND THE KNIFE TO BE DULL DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT KNIFE. THERE WAS NO HARM TO THE PATIENT. THE PRODUCT SAMPLE WAS RETAINED. NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224006 CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1832305H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other