BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 3941684 · Received July 17, 2014

    Report

    Report Number
    1226348-2014-11825
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 9, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    HBF
    PMA / PMN Number
    PK791101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    NO GTIN NUMBER AVAILABLE. UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE PERFORATOR WAS EVALUATED BY THE SUPPLIER AND IT WAS FOUND TO BE WITHIN SPECIFICATIONS. THIS PERFORATOR MET ALL VISUAL AND FUNCTIONAL TESTING REQUIREMENTS. THE ROOT CAUSE OF THE REPORTED "DID NOT DISENGAGE AND PLUNGED¿ WAS NOT DETERMINED. THE PERFORATOR MET FUNCTIONAL TEST METHOD ACCEPTANCE REQUIREMENTS; PROPER ENGAGEMENT AND DISENGAGEMENT WERE ACHIEVED WITH EVERY DRILL HOLE, THERE WAS NO PREMATURE DISENGAGEMENT, OR ERRATIC AND POOR CUTTING ACTION. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. ALL TEST AND INSPECTIONS ASSOCIATED WITH THE ASSEMBLY PROCESS MET SPECIFICATION REQUIREMENTS. WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    7/22/2014 ADDITIONAL INFORMATION EXPLAINED THAT THE REP REPORTED THAT NO ADVERSE CONSEQUENCES WERE VERIFIED. THEY REPLACED THE PERFORATOR AND THERE WAS NO DELAY. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    SALES REP. INFORMED THAT: "PERFORATOR DID NOT DISENGAGE AND PLUNGED INTO THE DURA. THEY REMOVED THE PERFORATOR AND REPLACED IT WITH A NEW ONE. IT DID NOT CAUSE A DELAY MORE THAN 30 MINUTES. PLEASE SEND THE EVALUATION RESULTS TO THE SALES REP". (B)(6) 2014 M- BASED ON THE REPORTED EVENT, THERE WAS NO MENTION THAT HARM WAS DONE TO THE PATIENT. AS A RESULT THE COMPLAINT WILL BE REPORTED AS A MALFUNCTION AS IT HAS THE POTENTIAL TO RESULT IN AN INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419966 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC HBF CODMAN & SHURTLEFF EG020S

    Patients

    Seq Age Sex Outcome Treatment
    1