BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON RONGUER

    MDR report key: 6864483 · Received September 14, 2017

    Report

    Report Number
    6864483
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    July 26, 2017
    Report Date
    August 14, 2017
    Manufacturer
    AESCULAP, INC
    Product Code
    KBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTICED THAT THE HEAD OF THE SCREW ON THE EJECTOR TIP KERRISON WAS MISSING. THE NURSE WAS UNABLE TO FIND THE SCREW SO FLAT PLATE X-RAY DONE TO RULE OUT RETAINED FOREIGN OBJECT (RFO). XRAY CONFIRMED NO RFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646412 KERRISON RONGUER AESCULAP KERRISON RONGUER KBB AESCULAP, INC FK927B UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR