BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 7249640 · Received February 7, 2018

    Report

    Report Number
    3005075853-2018-07843
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 1, 2017
    Report Date
    January 25, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    20705036000935
    PMA / PMN Number
    K042777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # K90999. INVESTIGATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT AN ACE36E DEVICE WAS RETURNED OUTSIDE ITS ORIGINAL PACKAGE. ONLY THE TYVEK WAS RETURNED FOR ANALYSIS. THE TYVEK WAS VISUALLY INSPECTED AND NO DAMAGE WAS OBSERVED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSE THE REPORTED EVENT. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. DEVICE HISTORY LOT: NULL, DEVICE HISTORY REVIEW: NULL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THAT DEVICE'S PACKAGE FOR DAMAGED. THE STERILITY WAS COMPROMISED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90821 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 20705036000935

    Patients

    Seq Age Sex Outcome Treatment
    1