BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONLY F/MODULAR MONOPOL.ELECTR

    MDR report key: 7325381 · Received March 8, 2018

    Report

    Report Number
    9610612-2018-00082
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Report Date
    March 12, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT VISUALLY. THE WORKING END OF THE INSULATION SHAFT IS BURNT DUE TO AN ELECTRIC BREAKDOWN. CONCLUSION AND ROOT CAUSE: BSED ON THE INFORMATION AVALIABLE AS WELL A RESULT OF OUR INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONAL: MOST LIKELY MOISTURE ENTERED THROUGH AN EXISTING HAIR CRACK AND CAUSED AN INSULATION BREAKDOWN. THIS, IN TURN, LED TO AN ELECTRIC ARC, WHICH CAUSED THE DAMAGE OF THE OUTER TUBE. THE SHAFT MUST HAVE BEEN DAMAGED AFTER DELIVERY OF THE INSTRUMENTS. BASED ON THE INSPECTION OF THE QUALITY ASSURANCE, THE SHAFTS ARE INSPECTED FOR CRACKS 100% NO CAPA IS NECESSARY

    Description of Event or Problem · 0

    (B)(6). PLASTIC SHAFT HAS BURNED AND DAMAGED AT THE TOP DURING LAPAROSCOPIC INTERVENTION AND CAUSED MINOR PATIENT INJURY, PRODUCT IN WARRANTY. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: GK370P / SHAFT ONLY F/MODULAR MONOPOL.ELECTR, GK383R / CERAMIC ELECTRODE TIP J-HK F/GK372R, GK373R / INNER TUBE W/HANDLE FOR GK372R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166297 ONLY F/MODULAR MONOPOL.ELECTR ENDOSCOPY GEI AESCULAP AG GK370P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GK370P / SHAFT ONLY F/MODULAR MONOPOL.ELECTR| GK373R / INNER TUBE W/HANDLE FOR GK372R| GK383R / CERAMIC ELECTRODE TIP J-HK F/GK372R