BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3005075853-2019-17600

    MDR report key: 8458351 · Received March 27, 2019

    Report

    Report Number
    3005075853-2019-17600
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    March 11, 2019
    Report Date
    March 11, 2019
    PMA / PMN Number
    K132612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION SUMMARY: ACTUAL DEVICE WAS NOT RETURNED BUT TWO PHOTOS WERE RETURNED. UPON VISUAL INSPECTION OF TWO PHOTOS, THE FOLLOWING WAS OBSERVED: THE FIRST PHOTO SHOWS A SEALED PACKAGE WITH A HARMONIC DEVICE INSIDE, FROM TOP VIEW. ALSO, A DAMAGE WAS NOTED IN THE BLISTER OF LEFT SIDE NEAR OF HANDLE. THE SECOND PHOTO SHOWS A CORNER OF PACKAGE AND IT WAS NOTED THAT A LITTLE PART OF BLISTER IS MISSING; THAT IT EXTENDS FROM SEALING TO THE HANDLE OF DEVICE. ALSO, THE BATCH R9553H, CAN BE SEEN. BASED ON THE PHOTOS REVIEWED, NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # R9553H. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ONE UNIT WITH BROKEN PACKAGING, WHICH CONSEQUENTLY CAUSED THE STERILIZATION OF THE PRODUCT TO BE LOST. PACKAGING PROBLEM, THE PRODUCT IS IN PERFECT CONDITION. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE