BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACLEAN ELECTRODE 1"BLADE EXTENDED INSULATION

    MDR report key: 9545407 · Received January 3, 2020

    Report

    Report Number
    3007305485-2019-00437
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 6, 2019
    Report Date
    February 14, 2020
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE ORGINAL FILING DONE ON 1-3-20 STATED THE PRODUCT NUMBER WAS 139104EXT IN D2 AND IN G5 THE STATED 510K NUMBER WAS K991855. ADDITIONAL INFORMATION WAS RECEIVED THAT STATED THE ACTUAL PRODUCT NUMBER WAS 130317 AND THE 510K NUMBER IS K791137.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 130317 IN UNORIGINAL PACKAGING. LOT NUMBER COULD NOT BE VERIFIED. PERFORMED A VISUAL INSPECTION ON THE DEVICE, THERE WERE NO OBVIOUS SIGNS OF ABNORMALITIES OR DEFECTS. PERFORMED A FUNCTIONAL INSPECTION USING THE VERMONT PIN GAGES (C3244), ALL OF THE MEASUREMENTS WITHIN THE DEVICE WERE IN SPEC. A TWO-YEAR LOT HISTORY REVIEW COULD NOT BE REVIEWED SINCE A LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE DHR COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 6 COMPLAINTS REGARDING 10 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; THESE DEVICES SHOULD BE INSPECTED BEFORE EACH USE AND SHOULD NOT BE USED IF DAMAGE IS FOUND. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE INCLUDING: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS; BROKEN OR SIGNIFICANTLY BENT CONNECTOR CONTACTS; AND VERIFY THAT THE ELECTRODE IS FULLY AND SECURELY SEATED IN THE HANDPIECE BEFORE USE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED AND THE COMPLAINT INVESTIGATION IS ONGOING. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION AND DEVICE EVALUATION. 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 139104EXT, ULTRACLEAN ELECTRODE BLADE USED WITH THE PENCIL WAS LOOSE AND FELL INTO PATIENT'S MOUTH DURING SURGERY. AS PER CUSTOMER THIS WAS THE FIRST USE OF THE PENCIL AND THE BLADE WAS PROBABLY LOOSE SINCE BEGINNING OF THE PROCEDURE. THE BLADE WAS REMOVED FROM THE PATIENT MOUTH. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT. THE PROCEDURE WAS COMPLETED USING ANOTHER PENCIL. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6545 ULTRACLEAN ELECTRODE 1"BLADE EXTENDED INSULATION ULTRACLEAN ELECTORDE GEI CONSOLIDATED MEDICAL EQUIPMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1