BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF SURGICAL

    MDR report key: 6970317 · Received October 23, 2017

    Report

    Report Number
    3005883396-2017-05099
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Report Date
    February 14, 2019
    Manufacturer
    MITG - RF SURGICAL SYSTEMS
    Product Code
    LWH
    UDI-DI
    10884521700703
    PMA / PMN Number
    K062642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE UNIT'S EXTERIOR FOUND THE FRONT HOUSING PANEL SEPARATED FRONT THE BOTTOM OF THE CHASSIS. THE TWO TABS ON THE BOTTOM OF THE FRONT HOUSING PANEL, THAT ACCEPT THE ATTACHING MACHINE SCREWS, ARE BROKEN. THE INVESTIGATION COULD NOT DETERMINE A ROOT CAUSE OR A PROBABLE ROOT CAUSE FOR THE CUSTOMER'S REPORT BASED ON THE INFORMATION PROVIDED. A FAILURE WAS FOUND DURING THE INVESTIGATION THAT DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED CONDITION. THE FRONT PANEL WAS FOUND TO BE DAMAGED. THE INVESTIGATION COULD NOT DETERMINE A ROOT CAUSE OR A PROBABLE ROOT CAUSE FOR THE DAMAGE. IT IS ADVISED THAT THE FRONT HOUSING PANEL BE REPLACED TO ADDRESS THE CONDITION. 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. 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

    THE INCIDENT SAMPLE WAS REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE OR ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD FALSE POSITIVE ALARM. NO PATIENT INJURY OCCURRED OR MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748534 RF SURGICAL COUNTER, SPONGE, SURGICAL LWH MITG - RF SURGICAL SYSTEMS 01-0043 10884521700703

    Patients

    Seq Age Sex Outcome Treatment
    1