BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECOLOGY DISPOSABL

    MDR report key: 2132947 · Received June 17, 2011

    Report

    Report Number
    3003604053-2011-00015
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE
    Product Code
    HIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ENTERED UTERINE CAVITY WHICH WAS BLOODY. ADVANCED THE BLADE INTO THE WORKING CHANNEL, IT WAS HARD TO SEE BECAUSE OF THE BLOOD. ONCE THE PICTURE BEGAN TO CLEAR AND SAMPLE WAS TAKEN SURGEON BEGAN TO REMOVE BLADE. SMALL PERFORATION WAS NOTICED. IT IS UNCLEAR IF IT WAS THE BLADE THAT CAUSED THIS AS IT WAS VERY DIFFICULT TO SEE. SURGEON DID USE A SMALLER DIAGNOSTIC HYSTEROSCOPE TO CONFIRM THAT IT WAS A SMALL PERFORATION. PATIENT WAS GIVEN ADDITIONAL ELECTROLYTES AND FOLLOW UP WILL INCLUDE AN ULTRASOUND. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECOLOGY DISPOSABL HYSTEROSCOPIC, ROTARY, MORCELLATOR HIH SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE 7209509

    Patients

    Seq Age Sex Outcome Treatment
    1