BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR HOOK ELECTRODE 3.5MM 290MM

    MDR report key: 4617984 · Received March 4, 2015

    Report

    Report Number
    2916714-2015-00178
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Date of Event
    January 23, 2015
    Report Date
    March 4, 2015
    Manufacturer
    AESCULAP AP & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K982623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG SITE EVAL: OUTWARDLY INSP: THE ELECTRODE ARRIVED DECONTAMINATED AND IN A BAD CONDITION. IT IS CLEARLY VISIBLE, THAT THE SHAFT IS BENT AND THE SHAFT DISPLAYED BURN MARKS. MICROSCOPIC INSP: UNDER THE MICROSCOPE IT CAN BE SEEN THAT A PART OF THE SHAFT INSULATION IS CHIPPED OFF. IN CONJUNCTION WITH RF-ENERGY, THIS LEAD TO THE BURNED SURFACE. ROOT CAUSE ANALYSIS: THE ROOT CAUSE FOR INSULATION DEFECTS LIKE THIS ARE HANDLING RELATED TO MICRO-CRACKS IN THE PLASTIC INSULATION. BENDING THE SHAFT AND ROUGH HANDLING DURING DECONTAMINATION CAN PROVOKE SUCH CRACKS. IN THE CASE AT HAND THE ELECTRODE WAS BENT IN THE PROXIMAL AREA AND CRACKS SEEN MICROSCOPICALLY. THE HOOK AREA ALSO DISPLAYED MICRO-CRACKS AND BENDING, WHEN VIEWED UNDER MAGNIFICATION. CONCLUSION: DAMAGES AS IN THE PRESENT CASE ENABLE THE IRRUPTION OF MOISTURE, DURING DECONTAMINATION. THROUGH CAPILLARY ACTION, MOISTURE ACCUMULATED BETWEEN THE ELECTRODE AND INSULATION. DURING THE OPERATION THE MOISTURE EVAPORATED AND, BECAUSE OF THE PRESSURE BETWEEN ELECTRODE AND INSULATION, THE INSULATION CHIPPED OFF, SHORTED AND ARCS AROSE. THESE ARE USER RELATED ISSUES.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING A LAPAROSCOPIC APPENDECTOMY WITH A GK 398 IT CAME TO AN BURNING ON THE PATIENTS BOWEL. ACCORDING TO THE SURGEON THIS CAUSED BY AN DEFECT ON THE GK 398. CURRENT NO MORE INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149715 MONOPOLAR HOOK ELECTRODE 3.5MM 290MM ELECTROSURGICAL DEVICE GCJ AESCULAP AP & CO. KG GK398R

    Patients

    Seq Age Sex Outcome Treatment
    1