BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 3023681 · Received March 27, 2013

    Report

    Report Number
    1226348-2013-14485
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    PK791101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY FOR COMPLAINTS OF THIS NATURE, THE RETURNED PERFORATORS HAVE BEEN VISUALLY INSPECTED AS RECEIVED, DISASSEMBLED AND CLEANED, AND THEN VISUALLY INSPECTED. NO DISCREPANCIES HAVE BEEN FOUND. THE PERFORATORS HAVE BEEN REASSEMBLED AND WERE FUNCTIONALLY TESTED FOR CUTTING AND DRILLING. THEY'VE BEEN FOUND TO MEET SPECIFICATION REQUIREMENTS. THE REPORTED CONDITION COULD NOT BE DUPLICATED. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE FOUND NO DISCREPANCIES. THE COMPLAINTS HAVE NOT BEEN CONFIRMED. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THERE WAS DISENGAGEMENT FAILURE DURING THE SURGERY. THE PERFORATOR WOULD NOT STOP AND CAUSED THE DURA INJURY. THE DURA INJURY WAS NOT SERIOUS AND HEMOSTASIS WAS DONE BY A BIPOLAR FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125458 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC HBF CODMAN & SHURTLEFF, INC. ME018S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention