BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP J-HK F/GK372R

    MDR report key: 5114972 · Received September 30, 2015

    Report

    Report Number
    2916714-2015-00845
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Report Date
    May 20, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THERE WERE NO NEGATIVE CONSEQUENCES FOR PATIENT. THE EQUIPMENT ARRIVED WITHOUT VISUAL DEFECTS. TEST AND ANALYSIS PERFORMED: MICROSCOPE AND DIGITAL CAMERA A VISIBLE INSPECTION OF THE HANDLE. IT LOOKS NEW WITHOUT ANY TRACES OF USAGE. THE CLAMPING MECHANISM FOR THE ELECTRODES WORKED WELL. THE CONNECTION PIN IN THE HANDLE PIECE IS FIX AND NOT BENT. THE ELECTRICAL RESISTANCE PIN-WORKING END IS LOWER THAN 1 AND THEREFORE IT IS OKAY. NEITHER HANDLE PIECE NOR THE SHAFT EXHIBIT ANY HINTS FOR INSULATION FAULTS OR DISRUPTIVE BREAKDOWNS. A VISIBLE INSPECTION OF THE CORD (GK246). AS WELL AS THE HANDLE, THE CABLE SHOWS NO VISIBLE TRACES OF USAGE. NO CRACKS OR PRESSURE MARKS. NEITHER THE PLUG NOR THE SOCKET EXHIBIT DAMAGED AREAS. THE ELECTRICAL RESISTANCE OF THE CORD IS LOWER THAN 1 AND IS THERE OKAY. NEITHER DURING BENDING THE CONNECTION AREA OF THE PLUG NOR THE BENDING OF THE AREA OF THE SOCKET CREATING ANY CONTACT INTERRUPTIONS. THE LAST TEST WAS THE RF-HOOK ELECTRODE. IT EXHIBITS NO SIGNS OF WEAR AND TEAR, NO BENDING OR INSULATION DEFECTS. THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. NONE OF THE COMPLAINED PRODUCTS SHOWS ANY DEFECT OR DEVIATION. THERE IS NO DEFECT IN THE PRODUCTS AND NO DESCRIPTION IN DETAIL WHAT KIND OF PROBLEM OCCURRED, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. ACCORDING TO SA-(B)(4) THERE IS NO CAPA NECESSARY.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INCIDENT INVOLVING RENU SET 4, A BOWEL INJURY OCCUR DURING A LAPAROSCOPIC SURGERY. COMPONENTS REPORTED- HANDLE F/MONOPOLAR ELECTRODES 5MM_PRODUCT # GK372R. MONOPOLAR CABLE W/LG.PIN 12FEET_PRODUCT # GK246.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645720 CERAMIC ELECTRODE TIP J-HK F/GK372R OTHER INSTRUMENTS GEI AESCULAP AG GK383R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other