BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMIDAL TIP, TROCAR

    MDR report key: 547163 · Received September 29, 2004

    Report

    Report Number
    1418479-2004-00030
    Event Type
    Injury
    Date Received
    September 29, 2004
    Date of Event
    August 3, 2004
    Report Date
    August 31, 2004
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    DRC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPY FOR A PELVIC MASS, THE PT'S DESCENDING COLON WAS PERFORATED UPON ENTERING OF THE ABDOMEN. A LAPAROTOMY WAS PERFORMED TO REPAIR THE COLON. THE POSSIBLITY OF HAVING TO DO AN OPEN SURGERY HAD ALREADY BEEN DISCUSSED PRIOR TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PYRAMIDAL TIP, TROCAR PYRAMIDAL TIP, TROCAR DRC RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8923.123 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R