BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLE

    MDR report key: 835689 · Received March 16, 2007

    Report

    Report Number
    835689
    Event Type
    Malfunction
    Date Received
    March 16, 2007
    Date of Event
    March 9, 2007
    Report Date
    March 16, 2007
    Manufacturer
    PHASE II MEDICAL MANUFACTURING, INC
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT UNDERWENT DILATATION & CURETTAGE (D&C), HYSTEROSCOPY, HYSTEROSCOPIC MYOMECTOMY, LAPAROSCOPY WITH LEFT SALPINGO-OOPHORECTOMY (LSO) AND PELVIC WASHINGS. DURING THE LAPAROSCOPY, A TINY PIECE OF THE TROCAR WAS MISSING. UNSURE IF PIECE WAS MISSING PRIOR TO USE. ABDOMINAL X-RAY OBTAINED POST PROCEDURE AND WAS CLEAR OF ANY FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLE TROCAR, CANNULA HET PHASE II MEDICAL MANUFACTURING, INC * FO86C
    2 APPLE TROCAR, CANNULA HET PHASE II MEDICAL MANUFACTURING, INC 900-802 F226A
    3 APPLE TROCAR, CANNULA HET APPLE MEDICAL CORPORATION 900-800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR