BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGADYNE ACE BLADE 700 ZIP E

    MDR report key: 8855738 · Received August 2, 2019

    Report

    Report Number
    1721194-2019-00106
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K141587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/5/2020 INVESTIGATION SUMMARY WE FOUND THAT THERE WAS A MISSING CORNER AT THE TIP OF THE BLADE AND THERE WAS A TRACE OF BURNING. WE SIMULATED THE FIRING TEST WITH THE SAME MODEL PRODUCT (SETTING CONDITION: CUT 50 WATT & COAG 50 WATT), AFTER 100 TIMES, IT DID NOT PRODUCE THE SAME CONDITION AS THE CUSTOMER COMPLAINT SAMPLE. MOREOVER, WE DIDN'T RECEIVE FURTHER INFORMATION ABOUT THE DEVICE DEFECTIVE SITUATION FROM THE END-USER. OUR TEAM WILL NEED MORE INFORMATION FEEDBACK FROM THE CLINICAL SPECIALIST WITH REGARDS TO PRODUCT USAGE CONDITIONS (E.G. THE DETAILED BACKGROUND OF THE INCIDENT, MATING DEVICE, ETC.). THEREFORE, NEW DEANTRONICS COULD NOT IDENTIFY THE ROOT CAUSE OF THIS CUSTOMER COMPLAINT. THE BATCH/LOT NUMBER DOES NOT MATCH AND CANNOT PERFORM THE DHR REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 8/2/2019. BATCH # UNK. FOLLOWING INFORMATION HAS BEEN REQUESTED BUT UNAVAILABLE: PLEASE CLARIFY: ¿CORNER PART OF THE BLADE CHIPPED OFF¿ DID THE CORNER OF THE ACTUAL BLADE BREAK OFF? DID THE COATING ON THE CORNER OF THE BLADE FLAKE OFF? ARE THERE ANY PLANS TO ATTEMPT TO LOCATE THE MISSING FRAGMENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST MASTOPEXY A CORNER PART OF THE BLADE CHIPPED OFF, GENERATING A FRAGMENT. IT IS UNKNOWN IF THE FRAGMENT WAS FOUND. A SIMILAR DEVICE WAS USED. THE PROCEDURE WAS NOT COMPLETE AT TIME OF SUBMISSION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651143 MEGADYNE ACE BLADE 700 ZIP E MEGADYNE ACE 700 ZIP PEN E CONNECTOR GEI MEGADYNE MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1