BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISION AUTOCLAVABLE SMALL JOINT ARTHROSCOPE

    MDR report key: 812077 · Received January 15, 2007

    Report

    Report Number
    8010418-2007-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2007
    Date of Event
    December 20, 2006
    Report Date
    December 20, 2006
    Manufacturer
    HENKE SASS WOLF
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REASON FOR FAILURE INVESTIGATION: A COMPLAINT WAS RECEIVED FROM CONMED-LINVATEC IN 2006. THE COMPLAINT STATED: SCOPE BROKE IN THE MIDDLE OF PROCEDURE. A COUPLE PIECES OF CYLINDER SHAPE GLASS WAS PROTRUDING OUT OF THE SCOPE. AS DR. PULLED THE SCOPE BACK A COUPLE OF PIECES FELL INTO PATIENT. THE DR. THINKS HE WAS ABLE TO RETRIEVE THE PIECES BUT IS NOT SURE. THERE WAS DELAY IN THE PROCEDURE. THE SCOPE WAS RECEIVED AT HSWOA ON DECEMBER 27, 2006. FAILURE INVESTIGATION CONCLUSION: THIS ENDOSCOPE WAS INSPECTED AT LINVATEC IN JANUARY 2002 AND SOLD IN 2005. FIELD CUSTOMER REPORTED THAT THIS WAS NOT THEIR FIRST USE OF THE SCOPE. AFTER EVALUATION, IT WAS FOUND THAT THE FOLLOWING COMPONENTS ARE NOT WITH THE SCOPE: NEGATIVE, FRONT LENS, FIELD LENS, MIDDLE ROD LENS, AND SIX SPACERS OF VARYING LENGTH. WHEN THE UNIT WAS BEING EVALUATED AT HSWOA, IT WAS NOTED THAT THERE WAS STILL CLEAR, CURED ADHESIVE LEFT AT THE TIP, AND THERE WERE ALSO MINOR DENTS ON THE OUTER DIAMETER OF THE DISTAL END. FIELD CUSTOMER REPORTED THAT "SCOPE WAS WHITE BALANCED AND INSERTED, BUT VISUALIZATION WAS POOR AND WHEN THE SCOPE WAS PULLED OUT THE (2) ROD LENSES FELL OUT." BASED ON THE ABOVE COMMENTS, THE NEGATIVE, FRONT LENS, FIELD LENS AND CORRESPONDING SPACERS COULD HAVE ALREADY BEEN OUT OF THE UNIT BEFORE IT WAS USED.

    Description of Event or Problem · 1

    SCOPE WAS INSERTED BUT VISUALIZATION WAS POOR. WHEN SCOPE WAS PULLED OUT, TWO (2) ROD LENSES FELL OUT - ONE INSIDE PATIENT AND ONE OUTSIDE. SURGICAL INTERVENTION REQUIRED TO REMOVE ROD LENSE. CONFIRMATION IS NEEDED TO DETERMINE IF THE SCOPE WAS INSPECTED BY END USER AFTER CLEANING AND STERILIZATION PRIOR TO USE. FAILURE INVESTIGATION COMPLETED BY HENKE SASS WOLF ON 12/28/2006. RESULTS INDICATED THAT PARTS WERE MISSING PRIOR TO SURGERY. MOST LIKELY THIS OCCURRED DURING CLEANING AND STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENVISION AUTOCLAVABLE SMALL JOINT ARTHROSCOPE HRX HRX HENKE SASS WOLF T1900R *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR