BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED TRUE HD LAPAROSCOPE

    MDR report key: 8901012 · Received August 16, 2019

    Report

    Report Number
    8901012
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    February 11, 2019
    Report Date
    June 27, 2019
    Manufacturer
    CONMED CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OUR CONMED HD CAMERAS MODEL # IM8120 HAVE DEVELOPED CRACKS IN THE OUTER CASING OF THE CAMERA HEADS WITHIN THE FIRST YEAR OF USE. THE CRACKS IN THE CAMERA HEADS HAS LED TO WATER DAMAGE OF THE CAMERA. OUT OF OUR 6 CAMERAS, 2 HAVE CRACKS AND ARE DAMAGED FROM WATER EXPOSURE. SINCE THIS ISSUE WAS IDENTIFIED WE HAD STARTED AND WILL CONTINUE TO CLEAN THE CAMERAS WITHOUT SUBMERGING THEM IN WATER WITH CLEANING SOLUTION. ALL STEPS IN THE CLEANING OF THE CAMERAS ARE BEING FOLLOWED EXCEPT THE CAMERAS ARE NO LONGER BEING SUBMERGED DURING THE CLEANING PROCESS TO PREVENT FURTHER DAMAGE, INSTEAD WE COVER THEM WITH A MIXED ENZYMATIC SOLUTION SOAKED CLOTH FOR THE DURATION OF THE INSTRUCTED CONTACT TIME PER THE ENZYMATIC INSTRUCTIONS FOLLOWED BY RINSING WITH COPIOUS AMOUNTS OF WATER. OUR REP WAS CONTACTED ABOUT THIS ISSUE AND NO OTHER RECOMMENDATIONS (OTHER THAN WHAT'S LISTED IN THE IFU'S) WERE GIVEN REGARDING THE CLEANING. NO INFORMATION WAS PROVIDED BY CONMED ABOUT PREVENTING FURTHER CRACKING OF THE CAMERA HEADS (ONLY A DISCUSSION ABOUT SIGNING A SERVICE AGREEMENT TO PROVIDE REPLACEMENTS) FOR THE EFFECTED UNITS. CONMED TECHNICAL SERVICE WAS NOT ABLE TO PROVIDE FEEDBACK AS TO THE CAUSE OF THE DAMAGE. THERE ARE NO CONNECTED HAI'S NOR HAVE ANY PATIENTS REQUIRED TREATMENT OR MONITORING FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696709 CONMED TRUE HD LAPAROSCOPE ENDOSCOPE VIDEO CAMERA GCJ CONMED CORPORATION IM8120

    Patients

    Seq Age Sex Outcome Treatment
    1