BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FMS UNKNOWN TUBING

    MDR report key: 2180374 · Received July 27, 2011

    Report

    Report Number
    1221934-2011-00276
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND THOROUGHLY EVALUATED AND TESTED: THE DEVICE HAD SOME MINOR COSMETIC SCRATCHES TO ITS CHASSIS, NO OTHER DAMAGE OR ANOMALIES NOTED; ALSO, THERE WERE SOME PERFORMANCE ISSUES THAT WERE CORRECTED. HOWEVER, THERE IS NOTHING IN THE DEVICE'S CONDITION THAT WOULD HAVE INFLUENCED THE REPORTED ISSUE. IN THE NARRATIVE IT INDICATES THAT THE PROBLEM WAS AT THE TOOL END WERE THE OUTFLOW TUBING CONNECTS, BOTH OF WHICH ARE WHICH ANCILLARY TO THE VAPR GENERATOR. A HYPOTHESIS FOR THE REPORTED ANOMALY MAY HAVE BEEN A HANDLING OR ASSEMBLY ISSUE BY THE USER; OUTSIDE OF THIS CONSIDERATION, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE REPORTED PROBLEM. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    OUR SALES REP IS REPORTING TO US THAT DURING SCOPE PORTION OF AN ARTHROSCOPIC KNEE REPAIR, THE OUTFLOW TUBING CAME AWAY AT THE TOOL END CAUSING OUTFLOW LIQUID TO CONTAMINATE THE STERILE FIELD. USED ANOTHER PUMP AND WALL SUCTION TO CONCLUDE THE PROCEDURE SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE COMPLAINT TUBING WAS DISCARDED AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK FMS UNKNOWN TUBING FLUID MANAGEMENT SYSTEM HRX DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1