BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USA ELITE SYSTEM RIGID OPTICAL TEARING BIOPSY

    MDR report key: 4648890 · Received March 30, 2015

    Report

    Report Number
    2951238-2015-00137
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 6, 2015
    Manufacturer
    GYRUS AMCI, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERRED TO IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE INSTRUMENT HAS FAILED DUE TO THE BREAKAGE OF THE FORCEPS PIN THAT HOLDS THE JAW TOGETHER AT THE DISTAL TIP. THIS CONDITION WOULD HAPPEN WHEN THE JAW HAS EXCESSIVE FORCE WHICH WOULD CAUSE THE WIRES TO BREAK OFF. IN ADDITION, THERE WAS A RUST STAIN ON THE DISTAL TIP AT THE BROKEN PIN AREA. THIS CONDITION MOSTLY HAPPENS DURING IMPROPER CLEANING OR REPROCESSING. PER THE INSTRUMENT MANUAL, HAND INSTRUMENTS MAY BE DAMAGED IF EXCESS FORCE IS APPLIED OR IF THE INSTRUMENT IS USED IN A MANNER FOR WHICH IT IS NOT INTENDED. IN ORDER TO AVOID DAMAGE, MAKE SURE THAT THE FORCE APPLIED TO THE HANDLE IS ADEQUATE AND REASONABLE FOR THE INTENDED APPLICATION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE INSTRUMENT FELL APART IN THE PT. THE PHYSICIAN WAS ABLE TO RETRIEVE ALL PARTS. THERE WAS NO REPORT OF PT INJURY. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN MORE DETAILED INFO ABOUT THE REPORTED EVENT BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207835 USA ELITE SYSTEM RIGID OPTICAL TEARING BIOPSY KNW GYRUS AMCI, INC. E8213 GT

    Patients

    Seq Age Sex Outcome Treatment
    1