BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 2990081 · Received February 26, 2013

    Report

    Report Number
    1060680-2013-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 4, 2013
    Manufacturer
    SWANN MORTON, LTD.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVENT OR PROBLEM: THE HOSPITAL REPORTED THAT 5 MONTHS PRIOR TO THE DATE OF THE EVENT, THAT THE BLADE BROKE WHEN REMOVED FROM ITS HANDLE. THIS IS THE SECOND TIME IT HAD HAPPENED AND ACCORDING TO STAFF IT IS A FREQUENT OCCURRENCE. DEROYAL: THE DEFECTIVE SAMPLE WAS NOT RETURNED FOR EVALUATION AND ROOT CAUSE INVESTIGATION. A SUPPLIER CORRECTIVE ACTION REQUEST WAS SUBMITTED TO (B)(4) FOR THEM TO EVALUATE THIS REPORTED EVENT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT 5 MONTHS PRIOR TO THE DATE OF THE EVENT, THAT THE BLADE BROKE WHEN REMOVED FROM ITS HANDLE. THIS IS THE SECOND TIME IT HAD HAPPENED AND ACCORDING TO STAFF IT IS A FREQUENT OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81652 DEROYAL GES- BLADE, SCALPEL GES SWANN MORTON, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other