BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN® MALIS® MODULE 1000¿INTEGRATED TUBING AND UNITIZED BIPOLAR CORD SET

    MDR report key: 3933847 · Received July 15, 2014

    Report

    Report Number
    1226348-2014-11813
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    April 9, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GEI
    PMA / PMN Number
    PK890648
    Product Problem
    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 PRODUCT WAS RETURNED AND WAS EVALUATED. ONE OF THE 3 TUBING SETS WAS FOUND TO BE OBSTRUCTED. THIS TUBING SET WAS SENT TO (B)(4) FOR FURTHER EVALUATION. THE OTHER 2 TUBING SETS WERE FOUND TO BE PATENT AND ANOMALY FREE. SUPPLIER EVALUATION REVEALED: (B)(4) HAS CONFIRMED THAT THE PROBLEM WAS BECAUSE OF EXCESS SOLVENT (CYCLOHEXANONE). THIS THE SAME PROBLEM THAT WE HAVE SEEN BEFORE, AND AS FAR AS I KNOW WE HAVE NOT SEEN A NEW COMPLAINT AFTER THE CORRECTIVE ACTIONS WERE IN PLACE FROM (B)(4). WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. (B)(4) HAS CONFIRMED THAT THE PROBLEM WAS BECAUSE OF EXCESS SOLVENT (CYCLOHEXANONE). THIS IS THE SAME PROBLEM THAT WE HAVE SEEN BEFORE, AND AS FAR AS WE KNOW WE HAVE NOT SEEN A NEW COMPLAINT AFTER THE CORRECTIVE ACTIONS WERE IN PLACE FROM ACCELLENT. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IMPOSSIBLE TO START IRRIGATION WITH THE BIPOLAR FORCEPS. THE PRIMING FROM THE PHYSIOLOGICAL SOLUTION COULD NOT BE PERFORMED. 4 TUBINGS WERE NEEDED BEFORE FINDING ONE TUBING FUNCTIONING. LOSS OF TIME. SURGEON UNSATISFIED. RISK OF INFECTION TO GET NEW DEVICES. ADDITIONAL INFORMATION RECEIVED: THE HOSPITAL CANNOT CONFIRM THE INFORMATION. BUT THE INCIDENT REPORT DOES NOT MENTION A DELAY GREATER THAN 30 MIN.

    Description of Event or Problem · 1

    (B)(6) 2014 ONE (OF THE 3 RETURNED) TUBING WAS SENT TO (B)(4) FOR FURTHER EVALUATION - BLOCKAGE CONFIRMED IN LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412203 CODMAN® MALIS® MODULE 1000¿INTEGRATED TUBING AND UNITIZED BIPOLAR CORD SET IRRIGATION TUBING SET, GENERAL PURPOSE GEI CODMAN & SHURTLEFF 372832

    Patients

    Seq Age Sex Outcome Treatment
    1