BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE

    MDR report key: 8395918 · Received March 6, 2019

    Report

    Report Number
    1717344-2019-00285
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 7, 2019
    Report Date
    April 4, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884524000626
    PMA / PMN Number
    K955836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED FOR EVALUATION. THE RETURNED PRODUCT MET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND NO DEFECTS. THE DEVICE CAME WITH AN ATTACHED ELECTRODE. THE REPORTED CONDITION WAS NOT CONFIRMED. THE INVESTIGATION FOUND NO EVIDENCE OF EXCESSIVE HEATING THE RETURNED PENCILS. THE DEVICE WAS PLUGGED INTO A GENERATOR AND ACTIVATED WITH SATISFACTORY RESULTS. NO ABNORMAL SPARKING OCCURRED. THE ELECTRODE DID NOT SHOW ANY ABNORMALITIES. THE DEVICE PASSED HIPOT TESTING INDICATING THAT WERE NO UNEXPECTED ELECTRICAL LEAKAGES. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. THE INSTRUCTIONS FOR USE (IFU) STATES, BOTH OXYGEN AND NITROUS OXIDE SUPPORT COMBUSTION. WATCH FOR ENRICHED OXYGEN AND NITROUS OXIDE ATMOSPHERES NEAR THE SURGICAL SITE, ESPECIALLY DURING HEAD AND NECK SURGERY. ENRICHED OXYGEN ATMOSPHERES MAY RESULT IN FIRES AND BURNS TO PATIENTS OR SURGICAL PERSONNEL. DO NOT EXCEED THE MAXIMUM POWER LIMITS AS STATED IN THE IFU. EXCEEDING THESE POWER LIMITS MAY RESULT IN PATIENT INJURY OR PRODUCT DAMAGE. IF THE ELECTRODE IS DAMAGED, DISCARD IT. ALWAYS USE THE LOWEST POWER SETTING TO ACHIEVE THE DESIRED SURGICAL EFFECT. THE MAXIMUM POWER SETTINGS ARE DETAILED IN THE INSTRUCTIONS FOR USE. SOME SURGEONS MAY ELECT TO BUZZ THE HEMOSTATS DURING A SURGICAL PROCEDURE. THIS PRACTICE IS NOT RECOMMENDED AND THE HAZARDS OF SUCH A PRACTICE PROBABLY CANNOT BE ELIMINATED. TO MINIMIZE THE RISK, WHEN USING COATED ELECTRODES, PLACE THE EDGE OF THE ELECTRODE AGAINST THE HEMOSTAT OR METAL INSTRUMENT TO ASSURE A GOOD ELECTRICAL PATHWAY. DO NOT ACTIVATE THE GENERATOR UNTIL THE ACCESSORY MAKES CONTACT WITH THE INSTRUMENT. ADDITIONAL MEASURES TO MINIMIZE THE RISK OF PERFORMING THIS TECHNIQUE ARE LISTED IN THE ELECTROSURGICAL GENERATOR USERS MANUALS. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A THORACOTOMY, A SPARK DISCHARGE OCCURRED FROM THE INSULATED CONNECTION PART BETWEEN THE PENCIL AND THE ELECTRODE OF THE PRODUCT AND AGAINST THE MUSCLE RETRACTOR NEARBY. IT WAS ALSO REPORTED THAT THERE WAS BLACK SOOT ATTACHED TO THE TIP OF THE PENCIL, BUT THE SALES REP RECEIVED THE PRODUCT AFTER IT HAD BEEN WASHED LIGHTLY WITH WATER BY THE NURSE, SO THEY COULD NOT CONFIRM THE ACTUAL CONDITION. THEY REPLACED THE HAND PIECE WITH A NEW ONE WHICH COULD BE USED WITHOUT PROBLEM. THE SUBCUTANEOUS POSITION IN THE PATIENT WAS GOT BURNT WITH A MINOR TISSUE DAMAGE WHICH REQUIRED NO SPECIAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189555 EDGE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER E2350H 10884524000626

    Patients

    Seq Age Sex Outcome Treatment
    1