BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 3841412 · Received May 30, 2014

    Report

    Report Number
    1226348-2014-11691
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    HBF
    PMA / PMN Number
    PK791101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S COMPLAINT OF "THE PERFORATOR COULD NOT STOP" WAS NOT VERIFIED. THE PERFORATOR MET FUNCTIONAL TEST METHOD ACCEPTANCE REQUIREMENTS; PROPER ENGAGEMENT AND DISENGAGEMENT WERE ACHIEVED WITH EVERY DRILLED HOLE, THERE WERE NO PREMATURE DISENGAGEMENT, OR ERRATIC AND POOR CUTTING ACTION. THE DEVICE HISTORY RECORDS (DHR) FOR THIS LOT (LOT# MF002S) OF PERFORATORS WAS REVIEWED. ALL TESTS AND INSPECTIONS ASSOCIATED WITH THE ASSEMBLY PROCESS MET SPECIFICATION REQUIREMENTS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    DISENGAGEMENT FAILURE WAS NOTED. DURING THE SURGERY, THE PERFORATOR COULD NOT STOP. NO INJURY TO THE PATIENT¿S DURA OR CEREBRAL PARENCHYMA WAS CONFIRMED. IT WAS REPORTED THAT THE PRODUCT WAS NOT REPROCESSED. THE BACKUP DEVICE WAS USED AND THE CASE WAS COMPLETED WITHOUT PROBLEM. THERE WERE NO SURGICAL DELAY GREATER THAN 30 MIN AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318274 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC HBF CODMAN & SHURTLEFF MF002S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention