BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR FORCEPS, POTTSMITH

    MDR report key: 819636 · Received January 23, 2007

    Report

    Report Number
    1530493-2007-00001
    Event Type
    Other
    Date Received
    January 23, 2007
    Date of Event
    May 12, 2006
    Report Date
    January 22, 2007
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN SECTION 5., OUR ENGINEERING DEPARTMENT FOUND NO FAULT WITH THE DEVICE AND COULD NOT REPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    PER COMPLAINANT, A DOCTOR AND NURSE WERE BOTH SHOCKED DURING THE PROCEDURE. NEITHER THE DOCTOR NOR THE NURSE WAS INJURED AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE END-USER SENT THE DEVICE BACK TO OUR CUSTOMER AND OUR CUSTOMER SENT THE DEVICE TO US. OUR ENGINEERING DEPARTMENT CONCLUDED ITS INVESTIGATION INTO THIS INCIDENT. ENGINEERING FOUND NO FAULT WITH THE DEVICE AND WAS NOT ABLE TO REPLICATE THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR FORCEPS, POTTSMITH MONOPOLAR FORCEPS GEI OLSEN MEDICAL 88-5240 121059

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other