BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICKLE KNIFE, POINTED TIP

    MDR report key: 167654 · Received May 14, 1998

    Report

    Report Number
    1418479-1998-00021
    Event Type
    Injury
    Date Received
    May 14, 1998
    Date of Event
    April 9, 1998
    Report Date
    April 15, 1998
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    KTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT WAS IN AN OUTPATIENT SURGICAL CENTER FOR: BILATERAL ENDOSCOPIC FRONTAL ETHMOID MAXILLARY AND LEFT SPHENOID SINUS SURGERY. A POINTED-TIP SICKLE KNIFE WAS BEING USED WHEN A "SNAP" WAS HEARD AND THE BLADE OF THE KNIFE WAS FOUND TO BE MISSING. THE SURGEON COULD NOT VISUALLY LOCATE IT. X-RAYS WERE TAKEN AND TIP WAS LOCATED. FOLLOWING EXTRACTION OF THE LOOSE BLADE, A CEREBRAL SPINAL FLUID LEAK WAS SEEN. THE SURGEON ATTEMPTED TO PATCH THE LEAK, BUT IT CONTINUED. THE PT WAS THEN ADMITTED FOR PLACEMENT OF A LUMBAR DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SICKLE KNIFE, POINTED TIP SICKLE KNIFE, POINTED TIP KTG RICHARD WOLF GMBH 8211.90 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R