BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N.A.

    MDR report key: 6306746 · Received February 7, 2017

    Report

    Report Number
    6306746
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 30, 2017
    Report Date
    February 6, 2017
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEURO RIGID VENTRICULOSCOPE FOR VENTRICULOSTOMY USING THE NON-DISPOSABLE BIPOLAR STORZ FOR ENDOSCOPY. SURGEONS COMPLAINED OF EQUIPMENT MALFUNCTION DURING CASE. SETTINGS ON APPROPRIATELY, COMPLAIN OF FLAME FROM BIPOLAR FROM THE NEUROSURGEON. THE PART NUMBERS OF THE TWO DEFECTIVE PIECES ARE KARL STORZ 26176LV- BIPOLAR CORD, AND 28762KB- BIPOLAR COAGULATION PROBE. THE PARTS HAVE BEEN SENT TO STORZ FOR EVALUATION.

    Description of Event or Problem · 1

    NEURO RIGID VENTRICULOSCOPE FOR VENTRICULOSTOMY USING THE NON-DISPOSABLE BIPOLAR STORZ FOR ENDOSCOPY. SURGEONS COMPLAINED OF EQUIPMENT MALFUNCTION DURING CASE. SETTINGS ON APPROPRIATELY, COMPLAIN OF FLAME FROM BIPOLAR FROM THE NEUROSURGEON. THE PART NUMBERS OF THE TWO DEFECTIVE PIECES ARE KARL STORZ 26176LV- BIPOLAR CORD, AND 28762KB- BIPOLAR COAGULATION PROBE. THE PARTS HAVE BEEN SENT TO STORZ FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91313 N.A. ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI KARL STORZ GMBH & CO. KG 26176LV

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR