BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC GI PROBE 2.3MM X 270CM

    MDR report key: 9878453 · Received March 25, 2020

    Report

    Report Number
    1320894-2020-00112
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 4, 2020
    Report Date
    May 6, 2020
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K990586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF COVID-19 PANDEMIC RESTRICTIONS, THE COMPLAINT DEVICE CANNOT BE RETURNED AT THIS TIME. WHEN THE DEVICE IS RETURNED, AN EVALUATION WILL BE PERFORMED, AND THE COMPLAINT FILE WILL BE UPDATED. A LOT HISTORY REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DHR REVIEW CANNOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 1 COMPLAINT REGARDING 1 DEVICE FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4)HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; DO NOT PULL ON, STRETCH, SEVERELY BEND OR KINK THE PROBE. USE OF THE PROBE WITH INSUFFICIENT ARGON GAS FLOW MAY SEVERELY DAMAGE THE TIP. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE 133270, ABC GI PROBE WAS USED ON (B)(6) 2020 DURING A COLONOSCOPY ON A PATIENT WITH RADIATION PROCTITIS. THEY APPLIED ARGON TO THE SITE AT 60W BUT WASN'T GETTING ENOUGH POWER SO THEY TURNED IT UP TO 80W. THE TIP OF THE PROBE BROKE OFF IN THE PATIENT (WAS RETRIEVED AND WILL BE RETURNED WITH THE PROBE.) THEY TOOK THE PROBE OUT AND GOT A NEW ONE AND FINISHED THE PROCEDURE. AFTER THE PROCEDURE THEY REALIZED THAT THERE WAS A HOLE IN THEIR SCOPE AND THEY BELIEVE THE ARGON GAS BLEW THROUGH A PINHOLE IN THE CATHETER OF THE PROBE AND DAMAGED THEIR SCOPE. THERE WAS A 2-MINUTE DELAY OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PROBE, ABC FLEX PROBE. THERE IS NO REPORTED PATIENT INJURY OR IMPACT. THIS REPORT IS BEING RAISED DUE TO DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344059 ABC GI PROBE 2.3MM X 270CM ABC ARGON FLEX PROBE GEI CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1