BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAZIER SUCTION TUBE

    MDR report key: 475728 · Received July 28, 2003

    Report

    Report Number
    475728
    Event Type
    Malfunction
    Date Received
    July 28, 2003
    Date of Event
    January 1, 2003
    Report Date
    January 1, 2003
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A HISTORY OF BILATERAL LEG PAIN AND LOW BACK PAIN. PRESENTED FOR LUMBAR LAMINECTOMY BILATERALLY, AT L3-4, LUMBAR LAMINECTOMY BILATERALLY AT L4-5 WITH HARVESTING OF BONE THROUGH SAME INCISION AND A TRANSVERSE PROCESS LATERAL ARTHRODESIS. A MIDLINE INCISION WAS PLACED AFTER X-RAY WAS TAKEN. ALL SOFT TISSSUE WAS TAKEN DOWN BY BOVIE AND BIPOLAR CAUTERIZATION. THE WOUND WAS COPIOUSLY IRRIGATED AND A SELF-RETAINING RETRACTOR WAS BROUGHT INTO THE FIELD AND PLACED. AT TIME OF CLOSURE, AFTER THE SOFT TISSUE HAD BEEN CLOSED IN THE PT, IT WAS FOUND THAT THERE WAS CLEAR FLUID EXUDING FROM THE #7 J-P LUMBAR DRAIN. IT WAS FELT THAT THIS WAS REPRESENTATIVE OF A SPINAL FLUID LEAK. THE WOUND WAS REOPENED, A LONGITUDINAL TEAR WAS FOUND ON THE PT'S LEFT SIDE. IT WAS ISOLATED AND USING MICROSCOPIC TECHNIQUE, WAS CLOSED USING 6-0 SUTURE. SURGERY WAS PROLONGED TO DETERMINE THE SOURCE OF CLEAR FLUID EXUDING FROM THE LUMBAR DRAIN AND TO SUTURE THE TEAR IN THE DURA. THE SURGEON FELT THE FRAZIER SUCTION TIP FROM THE DEEP BACK INSTRUMENT HAD A ROUGH EDGE, CAUSING THE TEAR TO THE DURA DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAZIER SUCTION TUBE (SUCTION TIP) DEEP BACK INSTRUMENT JOL SKLAR INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other