BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE MONOPOLAR CABLE

    MDR report key: 2192719 · Received June 9, 2011

    Report

    Report Number
    1530493-2011-00002
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 8, 2011
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    PRE-AMEND
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULT OF THE EVAL OF THE RETURNED DEVICE INDICATES THAT THE DEVICE MAY HAVE BEEN USED BEYOND 20 TIMES BECAUSE OF NOTICEABLE DEGRADATION ON THE COLOR OF THE COMPONENTS. OLSEN MEDICAL RECOMMENDS THAT THE DEVICE BE USED FOR NOT MORE THAN 20 STERILIZATION CYCLES AND ALSO INSPECT CABLES FOR DAMAGE PRIOR TO EACH USE. PROPER MAINTENANCE AND CARE OF THE DEVICE IS IMPORTANT FOR SAFE OPERATION.

    Description of Event or Problem · 1

    WHILE DOING A ROBOT-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY (DAVINCI HYSTERECTOMY) WITH USE OF A (B)(4) CORD WITH THE ELECTRO SURGICAL UNIT, WHEN ALL OF A SUDDEN THE CORD ATTACHED TO THE MACHINE WAS ON FIRE. THE PHYSICIAN TURNED THE MACHINE OFF, CHANGED CABLE, INFORMED BIOMED AND PRECEDED WITH THE CASE. THERE WAS NO INJURY TO THE PT OR STAFF AND NO SURGICAL OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE MONOPOLAR CABLE REUSABLE MONOPOLAR CABLE GEI OLSEN MEDICAL NA 014053

    Patients

    Seq Age Sex Outcome Treatment
    1