BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSTR.NON ARTICUL. D:5/360MM

    MDR report key: 3844776 · Received March 12, 2014

    Report

    Report Number
    2916714-2014-00133
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Report Date
    March 5, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K1110824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K): K130596. US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFR SITE EVAL: VISUAL INSPECTION: INSTRUMENTS ARRIVED UNPACKED AND CONTAMINATED. ONE OF THE PL720SU INSTRUMENTS ARRIVED WITHOUT THE GREEN ROTATION KNOB. EVAL RESULTS ARE FOR THE PL720SU WITHOUT THE ROTATION KNOB: THE JAWS OF THE INSTRUMENT DISPLAYED ONLY MINOR CONTAMINATION (DRIED BLOOD). ELECTRICAL AND MECHANICAL PARAMETERS WERE EVALUATED. THE ELECTRICAL PARAMETERS ARE WITHIN SPEC. THE MECHANICAL PARAMETERS ARE WITHIN SPEC, WITH EXCEPTION OF THE PIVOT JAW (HEAVY CONTAMINATION UNDERNEATH THE JAW MAKES CORRECT FUNCTION IMPOSSIBLE). AS A RESULT OF THE CONTAMINATION, THE PRESSURE DISTRIBUTION IS OUT OF SPEC.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). AFTER USING THESE PRODUCTS FOR TWO MONTHS (CAIMAN PL720SU AND PL730SU), THE SEALING PERFORMANCE IS SUDDENLY NO LONGER SATISFACTORY. AFTER THE ACOUSTIC "O. K." SIGNAL, THERE IS STILL BLEEDING, EVEN ON ANAEMIC TISSUE. DEVICE 1 OF 3. SEE 2916714-2014-00134, 00135.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149131 CAIMAN DISP.INSTR.NON ARTICUL. D:5/360MM GEI AESCULAP AG & CO. KG PL720SU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other