BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINISITE LAPAROSCOPE

    MDR report key: 38362 · Received September 11, 1996

    Report

    Report Number
    2027803-1996-00001
    Event Type
    Injury
    Date Received
    September 11, 1996
    Date of Event
    May 6, 1996
    Report Date
    September 11, 1996
    Manufacturer
    IMAGYN MEDICAL, INC.
    Product Code
    HET
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS USED DURING A LAPAROSCOPICALLY VAGINAL HYSTERECTOMY. VISIBILITY WAS REPORTEDLY COMPROMISED DURING THE PROCEDURE RESULTING IN LACERATION OF THE BLADDER BY AN UNSPECIFIED DEVICE. A FORMAL LAPAROTOMY WAS PERFORMED AND THE LACERATION WAS REPAIRED. HOSP REPORTEED PT'S STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINISITE LAPAROSCOPE LAPAROSCOPE HET IMAGYN MEDICAL, INC. NONE GA-0006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention