BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOLF SICKLE KNIFE

    MDR report key: 163277 · Received April 17, 1998

    Report

    Report Number
    163277
    Event Type
    Injury
    Date Received
    April 17, 1998
    Date of Event
    April 9, 1998
    Report Date
    April 15, 1998
    Manufacturer
    RICHARD WOLF MED INSTRUMENTS CORP.
    Product Code
    KTG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 39 YEAR OLD MALE IN OUTPATIENT SURGICAL CTR MAXILLARY AND LEFT SPHENOID SINUS SURGERY, SEPTOPLASTY AND NASAL TIP PLASTY. WHILE MD USING THE SICKLE KNIFE IN THE NOSE, SNAP HEARD, WHEN INSTRUMENT REMOVED FROM THE NOSE, THE MD & SCRUB NOTICED A PORTION OF THE BLADE MISSING FROM THE HANDLE. SURGEON UNABLE TO LOCATE THE BLADE VISUALLY AND X-RAY DONE IMMEDIATELY. LOCATED TIP AND MD REMOVED PIECE OF BLADE. AT THAT TIME A CEREBROSPINAL FLUID LEAK WAS NOTED FROM THE AREA OF THE CRIBRI-FORM PLATE. MD ATTEMPTED TO SEAL/PATCH LEAK BUT LEAK CONTINUED AND PT ADMITTED TO ANOTHER FACILITY FOR LUMBAR DRAIN PLACEMENT FOR DIVERSION AND OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOLF SICKLE KNIFE SICKLE KNIFE- SHARP KTG RICHARD WOLF MED INSTRUMENTS CORP. WOLF 8211.90 *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R CONTINUING LEAK. CURRENTLY ON NEURO FLOOR.| ADD'L SURGERY TO RETRIEVE BLADE TIP WHICH RESULTED| ANOTHER FACILITY TO HAVE DRAIN PLACED FOR| IN CSF (CEREBRAL SPINAL FLUID) LEAK. PT. TO