BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM

    MDR report key: 4713838 · Received April 15, 2015

    Report

    Report Number
    2916714-2015-00334
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Report Date
    January 11, 2016
    Manufacturer
    AESCULAP AG& CO. KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/ 510 (K) # K093075 / K130596. EVALUATION ON-GOING AT ORIGINAL MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: THE INSTRUMENT ARRIVED DECONTAMINATED IN THE ORIGINAL CARDBOARD- BOX. IT IS CLEARLY VISIBLE THAT THE PIN IS MISSING. FOR ROOT CAUSE ANALYSIS, WE DETACHED THE INSTRUMENT, AND IT WAS NOTED THAT THE RETAINER OF THE PIN WAS BROKEN INTO TWO PARTS. THE PIECES OF THE FRAGMENTS WERE LOST DURING THE FURTHER HANDLING OF THE DETACHED INSTRUMENT. THE RETAINER IS THE ONLY PART THAT KEEPS THE PIN IN THE CORRECT POSITION. DURING MICROSCOPE INSPECTION OF THE UPPER JAW, IT WAS EVIDENT THAT THE GUIDING SLOT EXHIBIT CHATTER MARKS AND A SMALL NOTCH AT THE END OF THE SLOT . THE NOTCH CAN EFFECT THE PIN, AND CAUSE THE PIN TO BOUNCE BY RELEASING THE RATCHET. DURING THIS BOUNCE, THE PIN CHANGES POSITION AND JAMS. THIS RESULTS IN A STRONG FORCE OF THE CLAMPING LEVER AND THE PLASTIC RETAINER BREAKS. THE COMPLAINED PL730SU SHOWS INDICATIONS OF A MANUFACTURING DEFICIENCY. CORRECTIVE / PREVENTIVE ACTION HAS BEEN INITIATED AT THE MANUFACTURING SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). PIVOT PIN OF THE JAW FELL OUT AND INTO THE SITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249378 CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM CUT AND SEAL DEVICE GEI AESCULAP AG& CO. KG PL730SU T395

    Patients

    Seq Age Sex Outcome Treatment
    1