BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECOLOGY CAPITAL

    MDR report key: 2082386 · Received May 9, 2011

    Report

    Report Number
    3003604053-2011-00007
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE
    Product Code
    HIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UTERUS WAS PERFORATED BY THE SCOPE/SHEATH COMBINATION DURING SURGERY; MORCELLATION WAS NOT OCCURRING AT THE TIME OF THE PERFORATION. SURGEON STATED THE PATIENT CERVIX WAS AN UNUSUAL SHAPE/CONFIGURATION AND SHE WAS HAVING DIFFICULTY NAVIGATING THE CERVICAL CANAL. SURGEON STATED SHE WAS RESPONSIBLE FOR THE PERFORATION. PATIENT REPORTED BY THE SURGEON, TO BE RECOVERING AT HOME OF (B)(6) 2011 WITH NO OTHER UNTOWARD EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECOLOGY CAPITAL TRUCLEAR OPERATIVE HYSTEROSCOPE 8.0 HIH SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE 7209208

    Patients

    Seq Age Sex Outcome Treatment
    1