BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE

    MDR report key: 9560100 · Received January 7, 2020

    Report

    Report Number
    1223422-2020-00004
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 9, 2019
    Report Date
    January 7, 2020
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GEI
    UDI-DI
    00811099010012
    PMA / PMN Number
    K962119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED AN FDA MEDWATCH REPORT (MW5091846) ON 01/06/2020. THE REPORTED INCIDENT IS A HEAT SHRINK FAILURE ON A SCISSOR TIP. THE CATALOG NUMBER LISTED WAS 3152R AND THE LOT NUMBER 391406. MICROLINE SURGICAL DOES NOT USE AN R IN THEIR DISPOSABLE TIP CATALOG NUMBERS AND THIS LOT # IS NOT A MICROLINE NUMBER. THE INFORMATION OF THE REPORTING FACILITY WAS NOT PROVIDED ON THE MEDWATCH REPORT. THEREFORE WE CANNOT CONTACT THE REPORTER FOR MORE INFORMATION OR TO HAVE THE DEVICE RETURNED. WE BELIEVE THAT THE MICROLINE SURGICAL SCISSOR TIP WAS REPROCESSED BY ANOTHER ORGANIZATION PRIOR TO THIS FAILURE. MICROLINE SURGICAL DISPOSABLE TIPS ARE SINGLE USE DEVICES AND SHOULD NOT BE REPROCESSED OR REUSED. THE INSTRUCTIONS FOR USE (IFU) AND LABEL CLEARLY PROVIDE THIS INFORMATION. AS SUCH, WE CAN NOT BE RESPONSIBLE FOR A FAILURE OF A REPROCESSED DEVICE.

    Description of Event or Problem · 1

    A THIRD OF THE PROTECTIVE SHEATH CAME OFF THE END OF THE SCISSOR TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22374 RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL INC. 3152 UNKNOWN 00811099010012

    Patients

    Seq Age Sex Outcome Treatment
    1