BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 1210037 · Received May 22, 2008

    Report

    Report Number
    1720159-2008-00016
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 29, 2008
    Report Date
    May 6, 2008
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    k050161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED ELECTROSURGERY DISPATCHED A SYS 7550 TECH TO THE USER'S FACILITY TO PERFORM A COMPLETE EVAL. THE SUSPECT SYS 7550 WAS FOUND TO FUNCTION WITHIN ALL SPECS. THE USER FACILITY ASKED IF THE CONMED TECH WOULD TROUBLESHOOT THE VIDEO SYS. CONMED DOES NOT SUPPORT THE CONCOMITANT VIDEO SYS. THE USER FACILITY WAS USING, THEREFORE CONMED IS UNABLE TO FULFILL THE REQUEST TO TROUBLESHOOT. OUR TECH ADVISED THE USER FACILITY TO CONTACT THE VIDEO EQUIPMENT'S MFR (PENTAX AND SONY). REFERENCE DOCUMENTS: CONMED MEDWATCH# 1720159-2008-00010.

    Description of Event or Problem · 1

    THE CONMED MODEL 7550 ARGON BEAM COAGULATOR (ABC) WAS USED DURING A COLONOSCOPY PROCEDURE TO REPAIR BLEEDING IN THE BOWEL. SEVERAL ATTEMPTS WERE MADE TO COAGULATE THE TISSUE WITHOUT SUCCESS. IN ADDITION, THE VIDEO IMAGE ON THE SONY LMD1950MD DISPLAY WOULD BECOME DISTORTED THEN BLACKOUT WITH AN ERROR MESSAGE. THE ERROR READS "NO RGB CONNECTION". THE VIDEO IMAGE RETURNS TO NORMAL WHEN THE ABC ENERGY OUTPUT IS TURNED OFF AT THE FOOT SWITCH. THE COLONOSCOPY PROCEDURE WAS COMPLETED USING THIS SAME DEVICE IN THE BIPOLAR MODE. THE VIDEO SYSTEM WORKED FINE DURING THE USE OF BIPOLAR. USER FACILITY'S CLINICAL ENGINEERING EVAL: VISUAL INSPECTION IN 2008: AN EXTENSION LINE WAS USED BETWEEN THE PROBE AND THE 7550. THE FITTING THAT CONNECTS THE EXTENSION LINE TO THE 7550 HAD A BROKEN RUBBER O-RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED SYSTEM 7550 GEI CONMED ELECTROSURGERY 60-7550-120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR SONY VIDEO DISPLAY| PENTAX VIDEO PROCESSOR| PENTAX ENDOSCOPE