BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 3893597 · Received June 25, 2014

    Report

    Report Number
    1226348-2014-11747
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 2, 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

    SUPPLIER EVALUATION WAS RECEIVED ON 8/13/2014 AND REVEALED THE FOLLOWING: THE CUSTOMERS¿ COMPLAINT "DISENGAGE FAILURE" WAS NOT VERIFIED. THE PERFORATOR MET FUNCTIONAL TEST METHOD ACCEPTANCE REQUIREMENTS; PROPER ENGAGEMENT AND DISENGAGEMENT WERE ACHIEVED WITH EVERY DRILL HOLE, THERE WERE NO PREMATURE DISENGAGEMENT, OR ERRATIC AND POOR CUTTING ACTION. THE DEVICE HISTORY RECORDS FOR THIS PERFORATOR WERE REVIEWED. ALL ASSEMBLY PROCESS TESTS AND INSPECTIONS ASSOCIATED WITH ASSEMBLY PROCESS (INCLUDING 100% FUNCTIONAL TEST TO CODMAN (B)(4)), MET SPECIFICATION REQUIREMENTS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DISENGAGEMENT FAILURE WAS NOTED DURING SURGERY CONDUCTED FOR THE PATIENT WITH BRAIN TUMOR. PERFORATOR COULD NOT STOP AND CAUSED INJURY TO THE PATIENT¿S DURA. IT WAS REPORTED THAT THE PRODUCT WAS NOT REPROCESSED. THIS WAS OCCURRED WITH THE FIRST PERFORATION IN THE CASE. BLEEDING WAS STOPPED AND THE CASE WAS COMPLETED WITH THE SITE SUTURED. THERE WERE NO SURGICAL DELAY GREATER THAN 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370438 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC HBF CODMAN & SHURTLEFF BG021S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention