BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON RONGEUR

    MDR report key: 27586 · Received October 31, 1995

    Report

    Report Number
    MW1007527
    Event Type
    Malfunction
    Date Received
    October 31, 1995
    Date of Event
    August 30, 1995
    Report Date
    October 30, 1995
    Manufacturer
    PILLING WECK CO.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 28-YR-OLD FEMALE WAS ADMITTED ON 8/29/95 FOR VENTRICULAR SHUNT REPLACEMENT. ON 8/30/95 THE PT UNDERWENT SHUNT REPLACEMENT, DURING WHICH A RONGEUR WAS UTILIZED. DURING THE PROCEDURE, APPROX 1 CM OF THE TIP OF THE RONGUER WAS NOTED TO BE MISSING. THE SURGEON INDICATED THE PIECE MAY REMAIN IN THE EPIDURAL SPACE, BUT WAS UNCERTAIN. POST OPERATIVE CAT SCAN DID NOT REVEAL THE PRESENCE OF THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERRISON RONGEUR KERRISON RONGEUR HTX PILLING WECK CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other