BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPE CURVED SHEARS

    MDR report key: 3884211 · Received June 19, 2014

    Report

    Report Number
    3005075853-2014-04131
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    December 9, 2013
    Report Date
    June 13, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS ADDITIONAL INFORMATION: NO RETURN DEVICE THE DEVICE WAS NOT RETURNED ONLY THE INDIVIDUAL OPENED STERILE PACKAGE. DUE TO THE DEVICE WAS NOT RETURNED WE ARE UNABLE TO INVESTIGATE FURTHER THE REPORTED ISSUES. NO CONCLUSION COULD BE REACHED AS TO WHY THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SHEARS PRESENTED A RUPTURE OF THE LOWER BLADE. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359831 HARMONIC SCALPE CURVED SHEARS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA K4CX07

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE