BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO BALL PROBE

    MDR report key: 6471444 · Received April 7, 2017

    Report

    Report Number
    6471444
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    March 21, 2017
    Report Date
    March 29, 2017
    Manufacturer
    LIFE INSTRUMENT CORP.
    Product Code
    HXB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A MICRODISECTOMY ON THE PATIENT. SURGEON INSERTED A BALL-TIP PROBE TO FEEL UNDER A LIGAMENT, AND WHEN HE PULLED IT OUT, THE TIP BROKE OFF. IT WAS A SMALL 4MM LONG, 1 MM WIDE PIECE. THE SURGEON IMMEDIATELY RECOGNIZED THAT THE INSTRUMENT HAD BROKEN. HE CONTINUED TO DISSECT AND REMOVE THE LIGAMENT, ASSUMING THAT WE WOULD COME ACROSS THE METAL TIP IN THE PROCESS. EVENTUALLY STAFF BEGAN TO SEARCH THE DRAPES AROUND THE INCISION. THE METAL TIP WAS LOCATED ON THE DRAPE, AND IT APPEARED TO BE THE WHOLE PIECE THAT HAD BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254549 MICRO BALL PROBE PROBE HXB LIFE INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1