BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE MCL-S16 DIA 1.0MM SATALOFF [MXI]

    MDR report key: 3299236 · Received August 20, 2013

    Report

    Report Number
    9680837-2013-00039
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Report Date
    May 24, 2012
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S
    Product Code
    KBG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE (SUCTION TUBE MCL-S16 DIA 1.0MM SATALOFF) WAS RETURNED FOR EVALUATION. ANALYSIS INDICATED THAT THE TIP OF THE INSTRUMENT IS BROKEN. A FULL INVESTIGATION COULD NOT BE PERFORMED SINCE THE BROKEN TIP WAS NOT RETURNED. THEREFORE THE ROOT CAUSE OF THE MALFUNCTION (BROKEN TIP) COULD NOT BE DETERMINED. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC¿S MXI FACILITY IN (B)(6). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. MXI CAPA (B)(4) WAS OPENED TO ADDRESS THESE ISSUES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE (SUCTION TUBE MCL-S16 DIA 1.0MM SATALOFF) HAD A BROKEN TIP. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402703 SUCTION TUBE MCL-S16 DIA 1.0MM SATALOFF [MXI] TROCAR, SINUS KBG MEDTRONIC XOMED INSTRUMENTATION S.A.S MCL-S16 02/12

    Patients

    Seq Age Sex Outcome Treatment
    1