BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNATIONAL HYFRECATOR 2000, 230V

    MDR report key: 9444359 · Received December 10, 2019

    Report

    Report Number
    3007305485-2019-00407
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 10, 2019
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE HYFRECATOR POWER CORD FOUND IT IS IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR SIGNIFICANT WEAR AND IS IN GOOD ELECTRICAL CONDITION. EVALUATION OF THE HYFRECATOR PER IP-800-002 FOUND THE OUTPUT POWER IS SLIGHTLY TOO LOW AND IS MIS-CALIBRATED RATHER THAN A HARDWARE FAULT AS NOT ALL DATA POINTS WERE OUT OF SPECIFICATION. THE HYFRECATOR WAS RECALIBRATED AND PASSED TESTING PER IP-800-002; THE TECHNICIAN NOTED THAT THE DEVICE WAS IN EXCELLENT CONDITION WITH NO SIGNS OF WEAR OR DAMAGE. EVALUATION OF THE PENCIL FOUND HAS RIPPLES AS THOUGH IT HAD BEEN WOUND ONTO A SMALL DIAMETER FORMER, OTHERWISE IT IS IN GOOD CONDITION. TIP ANTI-ROTATION FEATURE WORKS WELL. TIP RETENTION IS GOOD. THE SWITCHES HAVE LOW ON-RESISTANCE. RF CONTINUITY FROM THE 4MM PLUG TO THE TIP IS VERY POOR AND SO INTERMITTENT IT IS NOT POSSIBLE TO LOCALIZE THE POOR CONTINUITY TO A SINGLE CONNECTOR. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. FOR THE PENCIL A 2 YEAR LOT HISTORY REVIEW COULD NOT BE CONDUCTED, AS A LOT NUMBER WAS NOT PROVIDED. A DHR REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 10 COMPLAINTS REGARDING 10 DEVICES FOR (7-900-230) THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE (B)(4). A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 1 COMPLAINT REGARDING 1 DEVICE FOR (7-900-5) THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) DEVICES 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; REFER TO THE CONMED HYFRECATOR OPERATOR'S MANUAL INSTRUCTIONS PRIOR TO USE. PENCIL IFU ADVISES; DO NOT ALLOW THE DEVICE CABLE TO BE PARALLEL TO OR IN CLOSE PROXIMITY TO LEADS OR OTHER ELECTRICAL DEVICES. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 7-900-230, HYFRECATOR 2000 230V, ARCED AND ZAPPED A PATIENT AND DOCTOR DURING A PROCEDURE ON (B)(6) 2019. ADDITIONAL INFORMATION WAS RECEIVED THAT STATED THERE WAS NO INJURY OR IMPACT TO THE PATIENT. THE "ZAP" TO THE DOCTOR WAS MINOR AND CAUSED NO INJURY. THE SURGEON DECIDED TO USE ANOTHER PIECE OF EQUIPMENT TO DO THE PROCEDURE AND SENT THE DEVICE TO BE EVALUATED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO DELAY. THE HYFRECATOR PENCIL IS LISTED AS A CONCOMITANT DEVICE SINCE THE MACHINE ITSELF CANNOT CAUSE A "ZAP". 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
    1238348 INTERNATIONAL HYFRECATOR 2000, 230V HYFRECATOR EQUIPMENT GEI CONSOLIDATED MEDICAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1