BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4577262 · Received February 27, 2015

    Report

    Report Number
    2916714-2015-00148
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Report Date
    February 27, 2015
    Manufacturer
    AESCULAP AG & CO KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2015. PMA/510 (K) # K110824/K130596. MFG SITE EVAL: THE INSTRUMENT ARRIVED CONTAMINATED IN A PL720SU BOX. THE BODY OF THE INSTRUMENT SEEMS CLEAN, THE JAW WAS CONTAMINATED WITH DRIED BLOOD. ELECTRICAL INSPECTION: FIRST WE MEASURED THE ELECTRICAL RESISTANCE OF THE COMPLETE INSTRUMENT. FOR THIS PURPOSE WE CLAMPED AN PIECE OF TIM FOIL IN THE JAW, AND MEASURED THE UPPER AND LOWER LINK IN COMMON. IN THE REST POSITION THE RESISTANCE IS ACCORDING TO SPEC. DURING HANDLING, TURNING AND BENDING THE SHAFT, THE RESISTANCE DID NOT CHANGE SIGNIFICANTLY. THE BEHAVIOR IS ACCORDING TO SPEC. OPEN THE HANDLE FOR INVESTIGATION: AFTER OPENING THE HANDLE, WE INVESTIGATED THE SLIDING CONTACTS. THE PROXIMAL CONTACT AS WELL AS THE DISTAL CONTACTS ARE CLEAN AND ACCORDING TO SPEC. THERE WAS NO HINTS LIKE CONTAMINATION WHICH COULD LEAD TO A DROP OUT OR A SPORADIC CONTACT PROBLEM. THE INSIDE OF THE HANDLE IS CLEAN, NO POLLUTION, NO BLOOD SPOTS. THE MFG DOCUMENTS HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPEC DURING THE TIME OF PRODUCTION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INSUFFICIENT SEALING PERFORMANCE CAUSING BLEEDING. INSTRUMENT CLEANING DURING SURGERY 8 TIMES. PT REPORTEDLY HAS NO COAGULATION DISORDER. PROCEDURE: SLEVE GASTRECTOMY. TYPE OF VESSEL SEALING: VESSEL AND TISSUE, SINGLE DISSECTION VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140349 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM CUT AND SEAL DEVICE GEI AESCULAP AG & CO KG PL720SU 52053802

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR