BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSTR.ARTICULAT.D5/360MM

    MDR report key: 6360523 · Received February 27, 2017

    Report

    Report Number
    9610612-2017-00069
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    January 17, 2017
    Report Date
    June 29, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K151696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT THE COAGULATION DIDN'T WORK HALFWAY THROUGH THE SURGERY. DURING THE SURGERY THE JAW HAS BEEN ARCING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: -DIGITAL-CAMERA "PANASONIC DMC TZ8". FIRST WE MADE A VISIBLE INSPECTION OF THE JAW. EXCEPT THE BLOOD SOILING AN THE CHARRING WE FOUND NO FURTHER ABNORMITIES. THEN WE CHECKED THE MECHANICAL FUNCTION. THE CLAMPING AND THE CUTTING FUNCTION WORKED WELL. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION WHICH WAS VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: ONE PROBABLE ROOT CAUSE IN CASES LIKE THIS IS A NOT PROPER CLEANING DURING SURGERY, SO THAT CARBONIZED RESIDUES OF BLOOD OR TISSUE INITIATE AN ARC. A FURTHER POSSIBLE ROOT CAUSE IS A DAMAGED INSULATION TONGUE (DISSECTION CLIP). THIS DAMAGE CREATED BY WRONG HANDLING DURING CLEANING THE ELECTRODES. A DAMAGE DURING RF- GENERATOR FAILURES CAN BE EXCLUDED. BECAUSE THERE IS SUSPICION OF A DESIGN RELATED ASPECT TO THE FAILURE, WE HAVE ENTERED THIS FAILURE MODE INTO OUR CORRECTIVE AND PREVENTATIVE ACTIONS SYSTEM SO ARE WORKING ON A SOLUTION. CORRECTIVE ACTION: A CAPA FOR IMPROVEMENT AND A BETTER DURABILITY WAS STARTED ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143784 CAIMAN DISP.INSTR.ARTICULAT.D5/360MM ENDOSCOPY GEI AESCULAP AG PL741SU 52276150

    Patients

    Seq Age Sex Outcome Treatment
    1 Other