BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGADYNE ACE BLADE 700M ZIP E

    MDR report key: 16554303 · Received March 16, 2023

    Report

    Report Number
    1721194-2023-00053
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 11, 2023
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559105672
    PMA / PMN Number
    K141587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. LOT NUMBER WAS RECEIVED AND DHR IS PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/11/2023. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. PENCIL AND ELECTRODE WERE RECEIVED FOR ANALYSIS, UPON VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE ME725M1E ELECTRODE WAS RETURNED WITH THE BLACK INSULATION DETACHED AND RETURNED. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT 1910073, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRE-OP THE THE BREAST MASS EXCISION PROCEDURE THAT WHEN OPENING THE PRODUCT ONTO THE BACK TABLE, THE BLACK SLEEVE THAT MAKES THE BLADE, A MODIFIED TIP, CAME OFF. THIS HAPPENED PRIOR TO THE CASE WE OPENED A NEW DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437447 MEGADYNE ACE BLADE 700M ZIP E MEGADYNE ACE BLADE 700M ZIP GEI MEGADYNE MEDICAL PRODUCTS, INC. ME725M1E 1910073 10614559105672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown