BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5125455 · Received October 2, 2015

    Report

    Report Number
    2916714-2015-00872
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Report Date
    February 1, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    SEENARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING SITE EVALUATION: DEVICE RECEIVED HAS THE PIN FROM THE ROCKER OF THE LOWER JAW MISSING. VISUAL INSPECTION OF THE JAW INDICATED BLOOD SOILING AND THE ABSENT ROCKER. THE SEATING OF THE ROTATION KNOB WAS NOTED TO BE BROKEN. MECHANICAL FUNCTION WAS TESTED AND THE CLAMPING AND CUTTING BEHAVIOR WAS ACCORDING TO SPECIFICATION. THE INSTRUMENT WAS DECONTAMINATED AND DISASSEMBLED. MICROSCOPIC EVALUATION OF THE JAW INDICATED NOTCHING, WHICH IS NECESSARY TO DIX THE JUNCTION PIN INTO PLACE. MANUFACTURING DOCUMENTS WERE REVIEWED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE ROOT CAUSE OF THE MISSING PIN CAN BE ATTRIBUTED TO A MANUFACTURING DEFICIENCY. THE PIN WAS NOT CRIMPED AFTER PLACEMENT, WHICH ALLOWED IT TO BACK OUT OF ITS INTENDED PLACE. THE ROTATION KNOB WAS NOT MENTIONED IN THE REPORTED ISSUE, AND IS ASSUMED TO HAVE BEEN BROKEN DURING TRANSPORT. THIS IS AN ISOLATED INCIDENT; NO CORRECTIVE / PREVENTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    510 (K) # K1110824 / K130596 MANUFACTURING SITE EVALUATION: EVALUATION ON GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SHORTLY AFTER SURGERY BEGAN, THE SURGEON CLOSED THE JAW IN ORDER TO SEAL AND SUDDENLY THE LOWER PART OF JAW BROKE OFF HALFWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652870 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM SEAL & CUT INSTRUMENTS GEI AESCULAP AG PL720SU 52158932

    Patients

    Seq Age Sex Outcome Treatment
    1 Other