BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 8678952 · Received June 7, 2019

    Report

    Report Number
    1717344-2019-00735
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    May 9, 2019
    Report Date
    October 1, 2019
    Manufacturer
    NEW DEANTRONICS LTD
    Product Code
    GEI
    UDI-DI
    10884521750913
    PMA / PMN Number
    K182772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED, AND A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. A DHR REVIEW WAS COMPLETED. THERE WERE NO MANUFACTURING ISSUES RELATED TO THE COMPLAINT FOR THIS LOT NUMBER. INSPECTION OF THE DEVICE RESULTED IN NOTING THAT THE PINS ON THE PLUG MAY HAVE SOME BURN RESIDUE. THE COATING ON THE TOP OF THE ELECTRODE LOOKED DAMAGED. THE DEVICE PASSED THE FOLLOWING TESTS: ELECTRODE RESISTANCE, CUT SWITCH AND COAG SWITCH RESISTANCE, GENERATOR FUNCTION, NOZZLE EXTEND / RETRACT, AND ELECTRODE EXTEND / RETRACT. NO ADAPTER WAS PROVIDED. THE DEVICE AS RECEIVED MET THE SPECIFICATIONS AND PASSED FUNCTIONAL TESTING BUT NOT THE VISUAL INSPECTION. THIS COMPLAINT WILL BE CONSIDERED AS UNCONFIRMED FOR COMPONENT MALFUNCTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CAUTERY PENCIL ELECTRODE TIP IGNITED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING TOTAL ABDOMINAL HYSTERECTOMY (TAH), WITH GENERATOR USED SETTINGS CUT 60 COAGULATION 40. THE END OF TISSUE HANDLE TOUCHED WITH CAUTERY TIP WHICH FLAME ENSUED (FLAME LOOKED LIKE A LIT MATCH) WHICH THEN WENT OUT RIGHT AWAY ON ITS OWN. SMALL AMOUNT OF ESCHAR-NOT UNUSUAL AND TISSUE INJURY NOTED ON PATIENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING TOTAL ABDOMINAL HYSTERECTOMY (TAH), WITH GENERATOR USED SETTINGS CUT 60 COAGULATION 40. THE END OF TISSUE HANDLE TOUCHED WITH CAUTERY TIP WHICH FLAME ENSUED (FLAME LOOKED LIKE A LIT MATCH) WHICH THEN WENT OUT RIGHT AWAY ON ITS OWN. REPLACED WITH NEW SIMILAR DEVICE AND IT WORKED FINE WHICH COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471146 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI NEW DEANTRONICS LTD SEP6000 1811197X 10884521750913

    Patients

    Seq Age Sex Outcome Treatment
    1