BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW ELECTROCAUTERY PROBE, 34 CM (MODEL # 6924)

    MDR report key: 6415644 · Received March 17, 2017

    Report

    Report Number
    1223422-2017-00027
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    December 30, 2016
    Report Date
    March 17, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K981188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1223422-2017-00027. THE RETURNED DEVICE WAS INVESTIGATED AT MICROLINE SURGICAL, INC. THE DEVICE WAS RETURNED WITH PHYSICAL DAMAGES TO THE TIP. THE TREADS OF THE TIP WERE SHEARED. ALTHOUGH THE REMAINING PART OF THE TIP IS MISSING, A PROBABLE ROOT CAUSE OF THIS BREAKAGE COULD BE DUE TO APPLYING AN EXCESSIVE TORQUE FORCE. THERE WAS NO HARM TO THE PATIENT. LATE MDR NARRATIVE: MICROLINE SURGICAL, INC., IS SUBMITTING THIS LATE MDR 1223422-2017-00027 (PAST 30-DAYS) DUE TO THE STAFF RESPONSIBLE FOR THE INVESTIGATION LEAVING, AND LACK OF STAFF TO COMPLETE THE TASK, INCLUDING LACK OF FULL INFORMATION AVAILABLE ON THE COMPLAINT TO SUBMIT THE MDR. MICROLINE SURGICAL, INC., WILL CONTINUE TO ENSURE ITS DUE DILIGENCE IN POST-MARKET COMPLAINTS HANDLING, AND ENSURING THAT ALL REQUIREMENTS FOR THE MEDICAL DEVICE EMDR REPORTING HAVE BEEN MET.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE RENEW CAUTERY PROBE, 34 CM (MODEL #6924), TIP BROKE AND FELL INTO THE PATIENT. THE BROKEN TIP WAS RETRIEVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195659 RENEW ELECTROCAUTERY PROBE, 34 CM (MODEL # 6924) ELCTROSURGICAL CAUTERY PROBE GEI MICROLINE SURGICAL, INC. 6924 00122653

    Patients

    Seq Age Sex Outcome Treatment
    1 Other