BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT S INTREPID INCISIONAL INSTRUMENTS (WITH SHARPS INJURY PROTECTION)

    MDR report key: 6074437 · Received November 2, 2016

    Report

    Report Number
    2523835-2016-00810
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Report Date
    April 16, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    K110166
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE THAT HAS NOT YET 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 FOURTH OF EIGHT REPORTS FROM THIS FACILITY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE AVAILABLE SAMPLE HAS NOT YET BEEN RECEIVED BY MANUFACTURING FOR EVALUATION OF THIS REPORT OF A BLUNT KNIFE THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A PHOTO OF THE PRODUCT IS ATTACHED TO THE PARENT COMPLAINT FILE WHICH HAS BEEN REVIEWED BY THE INVESTIGATION SITE. THE PHOTO DOES NOT SHOW SUFFICIENT DETAIL THEREFORE, NO CLEAR MANUFACTURING DEFECTS CAN BE OBSERVED. 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 ARE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. AS NO SAMPLE HAS YET BEEN RECEIVED AND THE DEVICE HISTORY RECORD REVIEW OF THE PROVIDED LOT NUMBER INDICATES THAT THE PRODUCT WAS RELEASED ACCORDING TO ACCEPTANCE CRITERIA, THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER 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. DEFECTS, SUCH AS DULL BLADES, ARE REMOVED FROM THE LOT AND SCRAPPED. PENETRATION TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. 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

    ONE OPENED KNIFE SAMPLE WAS RECEIVED BY MANUFACTURING INSIDE OF A TRAY FOR THE REPORT OF BEING BLUNT. THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED FOR PENETRATION AND WAS FOUND TO BE CONFORMING. THE RETURNED SAMPLE WAS FOUND TO BE CONFORMING THEREFORE, A BLUNT KNIFE AS DESCRIBED IN THE COMPLAINT WAS NOT CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED FOR THE COMPLAINT AS DESCRIBED BY THE CUSTOMER. NO ACTION WAS TAKEN AS THE CUTTING INSTRUMENT WAS MANUFACTURED TO SPECIFICATIONS. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO FURTHER ACTIONS ARE REQUIRED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT MULTIPLE BLUNT KNIVES WERE EXPERIENCED DURING SEPARATE SURGERIES. ALTERNATE KNIVES WERE OBTAINED IN ORDER TO COMPLETE THE PROCEDURES WITH NO IMPACT TO ANY PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725820 CLEARCUT S INTREPID INCISIONAL INSTRUMENTS (WITH SHARPS INJURY PROTECTION) KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 153317M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other