BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 9914680 · Received April 2, 2020

    Report

    Report Number
    1717344-2020-00386
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 11, 2020
    Report Date
    June 12, 2020
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED, AND A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. THE DEVICE AS RECEIVED MET THE SPECIFICATIONS AND PASSED FUNCTIONAL TESTING. THE REPORTED CONDITION WAS NOT CONFIRMED. ACCORDING TO THE TECHNICIAN, PERFORMED THE FUNCTIONAL TEST ON THE GENERATOR, X- RAY EXAMINATION, AND MEASURE THE CLOSED CIRCUIT (ACTIVATION) RESISTANCE OF THE RETURNED SAMPLE, WITH THE FOLLOWING RESULTS: X-RAY EXAMINATION CONFIRMED THE PROCESSING ASSEMBLY OF THE RETURNED SAMPLE IS CORRECT. RESISTANCE THE RESISTANCE AND CABLE ASSEMBLY OF RETURNED SAMPLE MEETS THE DESIGNED SPECIFICATION. THE COATING ON THE TIP OF THE ELECTRODE LOOKED DAMAGED AND ESCHAR REMAINED ON THE TIP OF THE ELECTRODE." THE INVESTIGATION FOUND THE MOST PROBABLE CAUSE OF THE REPORTED EVENT TO BE THAT THE USER DID NOT KEEP THE ELECTRODE CLEAN AND FREE OF ESCHAR AS STATED IN THE INSTRUCTIONS FOR USE(IFU). THE CUSTOMER IS ADVISED TO FOLLOW DEVICE CLEANING INSTRUCTIONS OUTLINED IN THE IFU. PER THE IFU: "WARNING - TISSUE BUILDUP (ESCHAR) ON THE TIP OF AN ACTIVE ELECTRODE POSES A FIRE HAZARD, ESPECIALLY IN OXYGEN-ENRICHED ENVIRONMENTS. ESCHAR PLUS HIGH OXYGEN MAY CREATE EMBERS. KEEP THE ELECTRODE CLEAN AND FREE OF ALL DEBRIS." MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 PROCEDURE, A SMALL SPARK/FIRE IGNITED WHEN THE DEVICE TIP WAS IN CONTACT WITH THE PATIENT AND CONTINUED TO FLAME THE LENGTH OF THE TIP FOR ABOUT 4-5 SECONDS. TIP FELT UN-COATED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379181 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI NEW DEANTRONICS LTD SEP6000 10884521750913

    Patients

    Seq Age Sex Outcome Treatment
    1