BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6206344 · Received December 27, 2016

    Report

    Report Number
    9610612-2016-00019
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Report Date
    April 11, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K130596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: SWEDEN. IT WAS REPORTED THAT THE DEVICE STOPPED WORKING AFTER USING SEVERAL TIMES DURING THE SURGERY. ERROR SIGNALS OCCURRED REPEATEDLY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: DIGITAL-CAMERA "(B)(4)" FIRST WE MADE A VISIBLE INSPECTION OF THE JAW. EXCEPT 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 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)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856652 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM ENDOSCOPY GEI AESCULAP AG PL720SU 52257081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other