BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4617983 · Received March 4, 2015

    Report

    Report Number
    2916714-2015-00177
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Date of Event
    January 22, 2015
    Report Date
    November 13, 2015
    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

    PMA/510(K) # K110824/K103596. MFG SITE EVAL: EVAL ON-GOING.

    Additional Manufacturer Narrative · 1

    RECEIVED FOR EVALUATION: (B)(4) "CAIMAN" LOT NUMBER 52066936. OUTWARDLY VISUAL INSPECTION: THE INSTRUMENT ARRIVED CONTAMINATED IN A TIGHTLY SEALED PLASTIC CONTAINER. DEVICE DISPLAYED HEAVY BLOOD SOILING. ELECTRICAL INSPECTION: ELECTRICAL RESISTANCE OF THE COMPLETE INSTRUMENT WAS MEASURED BY CLAMPING A PIECE OF TIN FOIL IN THE JAW AND MEASURING THE UPPER AND LOWER LINKS IN COMMON. THE RESISTANCE OF THE PUSH BUTTON WAS ALSO MEASURED. RESULT OF ELECTRICAL TESTING: 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, EVEN TO VALUES OUT OF SPECIFICATION, UNTIL INFINITELY. OPENING THE HANDLE FOR INVESTIGATION: AFTER OPENING THE HANDLE, THE SLIDING CONTACTS WERE EVALUATED. THE PROXIMAL AND DISTAL CONTACTS EXHIBIT CONTAMINATES ON THE CONTACT SURFACE. IT IS PRESUMABLE THAT THE CONTAMINATES ARE THE REASONS FOR DROP OUTS AND INSUFFICIENT SEALING. CONCLUSION: THE ROOT CAUSE OF THIS CONTAMINATION IS BLOOD, WHICH PERCOLATES THROUGH THE SHAFT DURING SURGERY. IT IS ALSO THE CAUSE FOR THE HIGH RESISTANCE OF THE BUTTON. THE MANUFACTURING DOCUMENTS HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS DURING THE TIME OF PRODUCTION CORRECTIVE ACTION: ENGINEERING CHANGE INITIATED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE TWEEZER DID NOT COMPLETELY SEAL THE TISSUE. RESULTED IN BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149712 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM CUT AND SEAL DEVICE GEI AESCULAP, INC. PL720SU 52066936

    Patients

    Seq Age Sex Outcome Treatment
    1