BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARCUT INTREPID KNIVES

    MDR report key: 5079337 · Received September 15, 2015

    Report

    Report Number
    2523835-2015-00838
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    September 4, 2015
    Report Date
    January 20, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RETURNED FOR EVALUATION; 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. THE COMPLAINT INDICATED A SURGICAL NURSE WAS INJURED BY THE BLADE DUE TO AN "UNPROTECTED" BLADE. THE COMPLAINT FURTHER INDICATED A SUGGESTION TO USE A "FOAM" SHEATH AS BLADE PROTECTOR AND SHOWED A COMPARISON OF TWO BLADE STYLES. IT MUST BE NOTED THAT ALCON PRODUCES BOTH STYLES OF PRODUCT. ONE STYLE IS PROTECTED WITH A FOAM SHEATH, WHILE ANOTHER STYLE IS WITH A BP-TRAY. BOTH PRODUCTS ARE THEN PRIMARILY PACKAGED IN A BLISTER PACK AS A STERILE BARRIER. WHEN THE BLISTER PACK IS OPENED, THE CIRCULATING NURSE CAN THEN "DROP" THE PROTECTED PRODUCT ONTO THE SURGICAL TRAY WITHOUT TOUCHING ANYTHING IN THE STERILE FIELD/REGION OF THE SURGICAL SUITE. IN BOTH CASES, THE BLADES REMAIN PROTECTED FROM TOUCHING OTHER SURGICAL INSTRUMENTS AND WOULD REMAIN SHARP UNTIL HANDED TO THE SURGEON BY THE STERILE NURSE AFTER REMOVING THE PROTECTIVE MECHANISM (FOAM OR BP-TRAY). USER HANDLING IS THE MAIN ROOT CAUSE OF THE REPORTED INJURY. THE TWO BLADE STYLES ARE TWO(2) METHODS USED TO PROTECT THE BLADES FROM DAMAGE AS WELL AS PROTECTION FROM POTENTIAL HANDLING INJURY. IF THE NURSE WERE AWARE THAT THE 2ND VERSION IS A BP-TRAY (BLADE PROTECTOR TRAY) INSIDE THE BLISTER PACK, THEY WOULD HAVE REALIZED THAT IT DOES PROTECT BOTH THE BLADE AND THE HANDLER. JUST AS THE FOAM SHEATH STYLE NEEDED TO REMAIN WITH THE BLADE JUST BEFORE USE BY THE SURGEON, SO IS THE BP-TRAY NEED TO REMAIN WITH THE PRODUCT UNTIL BEFORE USE BY THE SURGEON WHEN THE BLADE IS HANDED OVER TO MAKE THE INCISION. 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

    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 NURSE REPORTED THAT A TECHNICIAN EXPERIENCED A KNIFE STICK WHILE SETTING UP THE KNIFE PRIOR TO THE START OF SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THERE WAS NO CONTACT BETWEEN THE SUBJECT KNIFE AND THE SCHEDULED PATIENT WHOSE PROCEDURE WAS DELAYED UNTIL THE SET UP AND ATTENDING TECHNICIAN WERE BOTH REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE TECHNICIAN THAT WAS STUCK AND NO ADDITIONAL INFORMATION IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610514 CLEARCUT INTREPID KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other