BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5589497 · Received April 20, 2016

    Report

    Report Number
    2916714-2016-00288
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    March 7, 2016
    Report Date
    August 15, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K130596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018 PREVIOUS 510(K) : K110824

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). BREAKAGE OF THE JAW AND RE-GRASP MESSAGE. NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ARRIVED CONTAMINATED WITH A DAMAGED LOWER JAW, AN ADDITIONAL BROKEN PIECE AND THE LEAF SPRING. THE INSTRUMENT WAS ANALYZED BY MICROSCOPE, DIGITAL AND HARDNESS TEST. THE INSTRUMENT WAS DECONTAMINATED BEFORE THE INVESTIGATION WAS PERFORMED. AFTER DECONTAMINATION A VISUAL COMPARISON WAS PERFORMED BETWEEN THE FRACTURE SURFACE OF THE COMPLAINED INSTRUMENT AND AN INSTRUMENT FROM PRODUCTION. THE FRACTURE SURFACE OF THE COMPLAINED INSTRUMENT IS EQUALLY GRAINED AS THE SURFACE OF THE NEW INSTRUMENT. DURING FURTHER INSPECTION OF THE JAW IT WAS NOTICED, THAT THE PIVOT HAD CROSSED THE DISSECTION CLIP. THIS POSITION EFFECTS THE INSULATION OF THE DEVICE. THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE ROOT CAUSE FOR THE FRACTURE OF THE TIP OF THE LOWER JAW WAS MECHANICAL OVERSTRESS, MOST PROBABLY USER RELATED. THE DESCRIBED ELECTRICAL SHORT WAS CAUSED BY THE CONDUCTION OF THE LOWER AND THE UPPER JAW AFTER THE LOWER JAW CROSSED OVER THE DISSECTION CLIP. THE MATERIAL, WHICH THE LOWER JAW WAS MADE OF IS COMPLETE WITHIN SPECIFICATION, THE MANUFACTURING DOCUMENTATION IS WITHOUT DEVIATION. THE CURRENT FAILURE RATE IS WITHIN RISK ANALYSIS AND THEREFORE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245626 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM CUT AND SEAL DEVICE GEI AESCULAP AG PL720SU 52195681

    Patients

    Seq Age Sex Outcome Treatment
    1 Other