BEUDAMED
    FDA Adverse Event Other Summary report: N

    STYLUS

    MDR report key: 3530576 · Received November 12, 2013

    Report

    Report Number
    3008845715-2013-00025
    Event Type
    Other
    Date Received
    November 12, 2013
    Date of Event
    September 1, 2013
    Report Date
    November 11, 2013
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    HNN
    PMA / PMN Number
    K822112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. UNUSED PRODUCT FROM THE SAME LOT REPORTED WILL BE RETURNED FOR EVALUATION. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT NUMBER REPORTED OR FINISHED GOOD PRODUCT MANUFACTURED WITH THE SAME BLADE COMPONENT LOT AVAILABLE. METHOD: THE ACTUAL DEVICE WILL NOT BE RETURNED. UNUSED PRODUCT FROM THE SAME LOT REPORTED WILL BE RETURNED FOR EVALUATION. RESULTS/CONCLUSIONS: THE ACTUAL DEVICE WILL NOT BE RETURNED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR CORRESPONDING ISSUES IDENTIFIED DURING THE MANUFACTURING PROCESSES OR AT THE FINAL INSPECTION. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED NOR PRODUCT MANUFACTURED WITH THE SAME BLADE COMPONENT LOT. HOWEVER SAMPLES FROM THE SAME PRODUCT CODE, DIFFERENT FINISHED GOOD LOT WERE EVALUATED AND FOUND IN COMPLIANCE. THE BLADE COMPONENT SUPPLIER WAS CONTACTED AND IT WAS CONFIRMED THAT THIS PRODUCT UNDERGOES SEVERAL WASHING POINTS PRIOR TO RELEASE AS WELL AS INSPECTIONS AT OUR FACILITY. UNUSED PRODUCT FROM THE SAME LOT REPORTED WILL BE RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. (B)(4). ITEM NUMBER 52-2662, STYLUS 2.65MM ANGLED BLADE AND TIP BEVEL UP, LOT MBKA040.

    Description of Event or Problem · 1

    THE PHACO BLADE LEAVES SILVERY GLEAMING METALLIC PARTICLES IN THE PHACO TUNNEL DURING SURGERY. IN 2 CASES THESE PARTICLES WERE ONLY DISCOVERED DAYS AFTER SURGERY UNDER THE SLIT LAMP AND HAD TO BE REMOVED DURING A SECOND INTERVENTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586028 STYLUS 2.65MM ANGLED BLADE AND TIP BEVEL UP HNN SURGICAL SPECIALTIES PUERTO RICO INC. 52-2662 MBKA040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention NONE MADE AVAILABLE