BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DIEGO BLADE

    MDR report key: 4915898 · Received July 15, 2015

    Report

    Report Number
    1037007-2015-00004
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 4, 2015
    Report Date
    December 7, 2015
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    ERL
    PMA / PMN Number
    K034004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT CONFIRMED AS THE REPORTED DAMAGE TO THE INSULATION WAS FOUND. THIS INVESTIGATION REPORT FINDS THAT THE MANUFACTURING AND ASSEMBLY PROCESS FOR THE 70139033 - PK 3MM STR AGG TURBINATE PERFORMED BY THE (B)(4) FACILITY IS IN CONTROL AND FINDS NO EVIDENCE THAT THERE WAS ANY ASSEMBLY RELATED VARIABLE THAT CONTRIBUTED TO THE REPORTED EVENT. THE FAILURE IS APPEARS TO BE INHERENTLY DESIGN RELATED AND HAS BEEN ADDRESSED THROUGH THE RELEASE OF THE (B)(4) BLADE WHICH HAS NOT EXPERIENCED ANY RELATED COMPLAINTS SINCE PRODUCT LAUNCH.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE PATIENT RECEIVED A SUPERFICIAL BURN ON THE NOSTRIL SKIN. ACCORDING TO THE SURGEON THE INSULATION OF THE BIPOLAR LOST INTEGRITY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE PATIENT RECEIVED A SUPERFICIAL BURN ON THE NOSTRIL SKIN. ACCORDING TO THE SURGEON THE INSULATION OF THE BIPOLAR LOST INTEGRITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458916 PK DIEGO BLADE DIEGO BLADE ERL GYRUS ACMI, INC. 70139033 IH753429

    Patients

    Seq Age Sex Outcome Treatment
    1 Other