BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4713814 · Received April 15, 2015

    Report

    Report Number
    2916714-2015-00335
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    October 13, 2014
    Report Date
    January 12, 2016
    Manufacturer
    AESCULAP, INC.
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: THE INSTRUMENT ARRIVED CONTAMINATED IN A PLASTIC BOX. THE BODY OF THE INSTRUMENT APPEARS CLEAN, THE JAW WERE CONTAMINATED WITH DRIED BLOOD. THE ROTATION KNOB WAS DETACHED, A PART OF THE INSULATION OF THE UPPER JAW WAS CHIPPED OFF. THE ELECTRICAL RESISTANCE OF THE COMPLETE INSTRUMENT WAS MEASURED BY CLAMPING A PIECE OF TIN FOIL IN THE JAW, AND MEASURING THE UPPER AND THE LOWER LINK IN COMMON. IN THE REST POSITION THE RESISTANCE IS ACCORDING TO SPECIFICATION (LOWER THAN 4 OHM). DURING HANDLING, TURNING AND BENDING THE SHAFT, THE RESISTANCE CHANGES PERMANENTLY, SOMETIMES UP TO INFINITELY. THIS BEHAVIOR IS UNUSUAL AND NOT ACCORDING TO SPECIFICATION. AFTER OPENING THE HANDLE, THE SLIDING CONTACTS WERE INVESTIGATED. THE PROXIMAL CONTACT WAS CLEAN AND ACCORDING TO SPECIFICATION. THE DISTAL CONTACT WAS SOILED WITH BLOOD. BLOOD, ESPECIALLY DRIED BLOOD, HAS A SIGNIFICANTLY HIGHER RESISTANCE THAN COPPER OR STEEL, WHICH WOULD LEAD TO THE FAILURE NOTED. THE SOILED ELECTRICAL CONTACT WAS THE ROOT CAUSE FOR THE MALFUNCTION. THE SOILING WAS CAUSED BY BLOOD, WHICH LEAKED OUT OF THE SHAFT INTO THE HANDLE. THE MANUFACTURING DOCUMENTS WERE REVEIWED AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS VALID DURING THE TIME OF PRODUCTION. THE FAILURE RATE IS WITHIN THE ACCEPTABLE RANGE OF THE RISK ANALYSIS, NO FURTHER ACTIONS REQUIRED; HOWEVER, THERE HAS BEEN AN ENGINEERING CHANGE INITIATED.

    Additional Manufacturer Narrative · 1

    PMA/510 (K): # K09307/K130596. EVALUATION ON-GOING AT ORIGINAL MANUFACTRUING SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE CAIMAN TWEEZERS/FORCEPS STOPPED WORKING; ACCORDING TO THE INDICATION OF THE SURGEON, DID NOT CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249374 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM CUT AND SEAL DEVICE GEI AESCULAP, INC. PL702SU 52035636

    Patients

    Seq Age Sex Outcome Treatment
    1